2019 ADA standards of medical care in diabetes

Vinh Pham Nguyen
Vinh Pham Nguyen
••
Santé & Médecine

2019 ADA standards of medical care in diabetes

2019 ADA standards of medical care in diabetes

••
Vinh Pham Nguyen
Vinh Pham Nguyen
Santé & Médecine

2019 ADA standards of medical care in diabetes

2019 ADA standards of medical care in diabetes

1  sur  204
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
American Diabetes Association Standards of Medical Care in Diabetesd2019
2019 ADA standards of medical care in diabetes
[T]he simple word Care may suffice to express [the journal’s] philosophical mission. The new journal is designed to promote better patient care by serving the expanded needs of all health professionals committed to the care of patients with diabetes. As such, the American Diabetes Association views Diabetes Care as a reaffirmation of Francis Weld Peabody’s contention that “the secret of the care of the patient is in caring for the patient.” —Norbert Freinkel, Diabetes Care, January-February 1978 EDITOR IN CHIEF Matthew C. Riddle, MD ASSOCIATE EDITORS George Bakris, MD Lawrence Blonde, MD, FACP Andrew J.M. Boulton, MD David D’Alessio, MD Eddie L. Greene, MD Korey K. Hood, PhD Frank B. Hu, MD, MPH, PhD Steven E. Kahn, MB, ChB Sanjay Kaul, MD, FACC, FAHA Derek LeRoith, MD, PhD Robert G. Moses, MD Stephen Rich, PhD Julio Rosenstock, MD Judith Wylie-Rosett, EdD, RD EDITORIAL BOARD Andrew J. Ahmann, MD Vanita R. Aroda, MD Linda A. Barbour, MD, MSPH Roy W. Beck, MD, PhD Gianni Bellomo, MD Geremia Bolli, MD John B. Buse, MD, PhD Sonia Caprio, MD Jessica R. Castle, MD Robert J. Chilton, DO, FACC, FAHA Kenneth Cusi, MD, FACP, FACE J. Hans DeVries, MD, PhD Ele Ferrannini, MD Thomas W. Gardner, MD, MS Jennifer Green, MD Meredith A. Hawkins, MD, MS Petr Heneberg, RNDr, PhD Norbert Hermanns, PhD, MSc Irl B. Hirsch, MD, MACP Reinhard W. Holl, MD, PhD Philip Home, DM, DPhil George S. Jeha, MD Lee M. Kaplan, MD, PhD M. Sue Kirkman, MD Ildiko Lingvay, MD, MPH, MSCS Maureen Monaghan, PhD, CDE Kristen J. Nadeau, MD, MS Gregory A. Nichols, PhD, MBA Kwame Osei, MD Kevin A. Peterson, MD, MPH, FRCS(Ed), FAAFP Ravi Retnakaran, MD, MSc, FRCPC Elizabeth Seaquist, MD Guntram Schernthaner, MD Jan S. Ulbrecht, MB, BS Ram Weiss, MD, PhD Deborah Wexler, MD, MSc Vincent C. Woo, MD, FRCPC Bernard Zinman, CM, MD, FRCPC, FACP AMERICAN DIABETES ASSOCIATION OFFICERS CHAIR OF THE BOARD Karen Talmadge, PhD PRESIDENT, MEDICINE & SCIENCE Jane Reusch, MD PRESIDENT, HEALTH CARE & EDUCATION Felicia Hill-Briggs, PhD, ABPP SECRETARY/TREASURER Michael Ching, CPA CHAIR OF THE BOARD-ELECT David J. Herrick, MBA PRESIDENT-ELECT, MEDICINE & SCIENCE Louis Philipson, MD PRESIDENT-ELECT, HEALTH CARE & EDUCATION Gretchen Youssef, MS, RD, CDE SECRETARY/TREASURER-ELECT Brian Bertha, JD, MBA CHIEF EXECUTIVE OFFICER Tracey D. Brown, MBA, BChE CHIEF SCIENTIFIC, MEDICAL & MISSION OFFICER William T. Cefalu, MD January 2019 Volume 42, Supplement 1 The mission of the American Diabetes Association is to prevent and cure diabetes and to improve the lives of all people affected by diabetes.
AMERICAN DIABETES ASSOCIATION PERSONNEL AND CONTACTS ASSOCIATE PUBLISHER, SCHOLARLY JOURNALS Christian S. Kohler EDITORIAL OFFICE DIRECTOR Lyn Reynolds PEER REVIEW MANAGER Shannon Potts ASSOCIATE MANAGER, PEER REVIEW Larissa M. Pouch DIRECTOR, SCHOLARLY JOURNALS Heather Norton Blackburn EDITORIAL CONTENT MANAGER Nancy C. Baldino TECHNICAL EDITORS Theresa Cooper Donna J. Reynolds DIRECTOR, MEMBERSHIP/SUBSCRIPTION SERVICES Donald Crowl SENIOR ADVERTISING MANAGER Julie DeVoss Graff jgraff@diabetes.org (703) 299-5511 ADVERTISING REPRESENTATIVES American Diabetes Association Paul Nalbandian Associate Publisher, Advertising & Sponsorships pnalbandian@diabetes.org (703) 549-1500, ext. 4806 Tina Auletta Senior Account Executive tauletta@diabetes.org (703) 549-1500, ext. 4809 PHARMACEUTICAL/DEVICE DIGITAL ADVERTISING The Walchli Tauber Group Maura Paoletti National Sales Manager maura.paoletti@wt-group.com (443) 512-8899, ext. 110 PRINT ISSN 0149-5992 ONLINE ISSN 1935-5548 PRINTED IN THE USA Diabetes Care is a journal for the health care practitioner that is intended to increase knowledge, stimulate research, and promote better management of people with diabetes. To achieve these goals, the journal publishes original research on human studies in the following categories: Clinical Care/Education/Nutrition/ Psychosocial Research, Epidemiology/Health Services Research, Emerging Technologies and Therapeutics, Pathophysiology/Complications, and Cardiovascular and Metabolic Risk. The journal also publishes ADA statements, consensus reports, clinically relevant review articles, letters to the editor, and health/medical news or points of view. Topics covered are of interest to clinically oriented physicians, researchers, epidemiologists, psychologists, diabetes educators, and other health professionals. More information about the journal can be found online at care.diabetesjournals.org. Copyright © 2018 by the American Diabetes Association, Inc. All rights reserved. Printed in the USA. Requests for permission to reuse content should be sent to Copyright Clearance Center at www.copyright.com or 222 Rosewood Dr., Danvers, MA 01923; phone: (978) 750-8400; fax: (978) 646-8600. Requests for permission to translate should be sent to Permissions Editor, American Diabetes Association, at permissions@diabetes.org. The American Diabetes Association reserves the right to reject any advertisement for any reason, which need not be disclosed to the party submitting the advertisement. Commercial reprint orders should be directed to Sheridan Content Services, (800) 635-7181, ext. 8065. Single issues of Diabetes Care can be ordered by calling toll-free (800) 232-3472, 8:30 A.M. to 5:00 P.M. EST, Monday through Friday. Outside the United States, call (703) 549-1500. Rates: $75 in the United States, $95 in Canada and Mexico, and $125 for all other countries. Diabetes Care is available online at care.diabetesjournals.org. Please call the numbers listed above, e-mail membership@diabetes.org, or visit the online journal for more information about submitting manuscripts, publication charges, ordering reprints, subscribing to the journal, becoming an ADA member, advertising, permission to reuse content, and the journal’s publication policies. Periodicals postage paid at Arlington, VA, and additional mailing offices.
January 2019 Volume 42, Supplement 1 Standards of Medical Care in Diabetes—2019 S1 Introduction S3 Professional Practice Committee S4 Summary of Revisions: Standards of Medical Care in Diabetes—2019 S7 1. Improving Care and Promoting Health in Populations Diabetes and Population Health Tailoring Treatment for Social Context S13 2. Classification and Diagnosis of Diabetes Classification Diagnostic Tests for Diabetes A1C Type 1 Diabetes Prediabetes and Type 2 Diabetes Gestational Diabetes Mellitus Cystic Fibrosis–Related Diabetes Posttransplantation Diabetes Mellitus Monogenic Diabetes Syndromes S29 3. Prevention or Delay of Type 2 Diabetes Lifestyle Interventions Pharmacologic Interventions Prevention of Cardiovascular Disease Diabetes Self-management Education and Support S34 4. Comprehensive Medical Evaluation and Assessment of Comorbidities Patient-Centered Collaborative Care Comprehensive Medical Evaluation Assessment of Comorbidities S46 5. Lifestyle Management Diabetes Self-management Education and Support Nutrition Therapy Physical Activity Smoking Cessation: Tobacco and e-Cigarettes Psychosocial Issues S61 6. Glycemic Targets Assessment of Glycemic Control A1C Goals Hypoglycemia Intercurrent Illness S71 7. Diabetes Technology Insulin Delivery Self-monitoring of Blood Glucose Continuous Glucose Monitors Automated Insulin Delivery S81 8. Obesity Management for the Treatment of Type 2 Diabetes Assessment Diet, Physical Activity, and Behavioral Therapy Pharmacotherapy Medical Devices for Weight Loss Metabolic Surgery S90 9. Pharmacologic Approaches to Glycemic Treatment Pharmacologic Therapy for Type 1 Diabetes Surgical Treatment for Type 1 Diabetes Pharmacologic Therapy for Type 2 Diabetes S103 10. Cardiovascular Disease and Risk Management Hypertension/Blood Pressure Control Lipid Management Antiplatelet Agents Cardiovascular Disease S124 11. Microvascular Complications and Foot Care Chronic Kidney Disease Diabetic Retinopathy Neuropathy Foot Care S139 12. Older Adults Neurocognitive Function Hypoglycemia Treatment Goals Lifestyle Management Pharmacologic Therapy Treatment in Skilled Nursing Facilities and Nursing Homes End-of-Life Care S148 13. Children and Adolescents Type 1 Diabetes Type 2 Diabetes Transition From Pediatric to Adult Care S165 14. Management of Diabetes in Pregnancy Diabetes in Pregnancy Preconception Counseling Glycemic Targets in Pregnancy Management of Gestational Diabetes Mellitus Management of Preexisting Type 1 Diabetes and Type 2 Diabetes in Pregnancy Pregnancy and Drug Considerations Postpartum Care S173 15. Diabetes Care in the Hospital Hospital Care Delivery Standards Glycemic Targets in Hospitalized Patients Bedside Blood Glucose Monitoring Antihyperglycemic Agents in Hospitalized Patients Hypoglycemia Medical Nutrition Therapy in the Hospital Self-management in the Hospital Standards for Special Situations Transition From the Acute Care Setting Preventing Admissions and Readmissions S182 16. Diabetes Advocacy Advocacy Statements S184 Disclosures S187 Index This issue is freely accessible online at care.diabetesjournals.org/content/42/Supplement_1. Keep up with the latest information for Diabetes Care and other ADA titles via Facebook (/ADAJournals) and Twitter (@ADA_Journals).
2019 ADA standards of medical care in diabetes
Introduction:StandardsofMedical Care in Diabetesd2019 Diabetes Care 2019;42(Suppl. 1):S1–S2 | https://doi.org/10.2337/dc19-SINT01 Diabetes is a complex, chronic illness requiring continuous medical care with multifactorial risk-reduction strategies beyond glycemic control. Ongoing pa- tient self-management education and support are critical to preventing acute complications and reducing the risk of long-term complications. Significant ev- idence exists that supports a range of interventions to improve diabetes out- comes. The American Diabetes Association’s (ADA’s) “Standards of Medical Care in Diabetes,”referredtoastheStandardsof Care, is intended to provide clinicians, patients, researchers, payers, and other interested individuals with the compo- nents of diabetes care, general treat- ment goals, and tools to evaluate the quality of care. The Standards of Care recommendations are not intended to preclude clinical judgment and must be applied in the context of excellent clinical care, with adjustments for in- dividual preferences, comorbidities, and other patient factors. For more detailed information about manage- ment of diabetes, please refer to Med- ical Management of Type 1 Diabetes (1) and Medical Management of Type 2 Diabetes (2). The recommendations include screen- ing, diagnostic, and therapeutic act- ions that are known or believed to favorably affect health outcomes of patients with diabetes. Many of these interventions have also been shown to be cost-effective (3). The ADA strives to improve and update the Standards of Care to ensure that clinicians, health plans, and policy makers can continue to rely on them as the most authoritative and current guidelines for diabetes care. To improve access, the Standards of Care is now available through ADA’s new interactive app, along with tools and calculators that can help guidepatientcare.To download the app, please visit professional.diabetes.org/ SOCapp. Readers who wish to com- ment on the 2019 Standards of Care are invited to do so at professional. diabetes.org/SOC. ADA STANDARDS, STATEMENTS, REPORTS, and REVIEWS TheADAhasbeenactivelyinvolvedinthe development and dissemination of di- abetes care standards, guidelines, and related documents for over 25 years. The ADA’s clinical practice recommendations are viewed as important resources for health care professionals who care for people with diabetes. Standards of Care This document is an official ADA posi- tion, is authored by the ADA, and pro- vides all of the ADA’s current clinical practice recommendations. To update the Standards of Care, the ADA’s Professional Practice Committee (PPC) performs an extensive clinical di- abetes literature search, supple- mented with input from ADA staff and the medical community at large. The PPC updates the Standards of Care annually. However, the Standards of Care is a “living” document, where notable up- dates are incorporated online should the PPC determine that new evidence or regulatory changes (e.g., drug approvals, label changes) merit immediate inclusion. Moreinformationonthe“livingStandards” can be found on DiabetesPro at profes- sional.diabetes.org/content-page/living- standards. The Standards of Care supersedes all previous ADA position statementsdand the recommendations thereindon clinical topics within the purview of the Standards of Care; ADA position statements, while still con- taining valuable analysis, should not be considered the ADA’s current position. The Standards of Care receives annual review and approval by the ADA Board of Directors. ADA Statement An ADA statement is an official ADA point of view or belief that does not contain clinical practice recommenda- tions and may be issued on advocacy, policy, economic, or medical issues re- lated to diabetes. ADA statements undergo a formal review process, including a review by the appropriate national committee, ADA mission staff, and the ADA Board of Directors. Consensus Report A consensus report of a particular topic contains a comprehensive examination and is authored by an expert panel (i.e., “Standards of Medical Care in Diabetes” was originally approved in 1988. Most recent review/revision: December 2018. © 2018 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license. Diabetes Care Volume 42, Supplement 1, January 2019 S1 INTRODUCTION
consensus panel) and represents the panel’s collective analysis, evaluation, and opinion. The need for a consensus report arises when clinicians, scientists, regulators, and/or policy makers desire guidance and/or clarity on a medical or scientific issue related to diabetes for which the evidence is contradictory, emerging, or incomplete. Consensus reports may also highlight gaps in evidence and propose areas of future research to address these gaps. A consensus report is not an ADA position and represents expert opinion only but is produced under the auspices of the Association by invited experts. A consensus report may be developed after an ADA Clinical Conference or Re- search Symposium. Scientific Review A scientific review is a balanced review and analysis of the literature on a scien- tific or medical topic related to diabetes. A scientific review is not an ADA po- sition and does not contain clinical prac- tice recommendations but is produced under the auspices of the Association by invited experts. The scientific review may provide a scientific rationale for clinical practice recommendations in the Standards of Care. The category may also include task force and expert committee reports. GRADING OF SCIENTIFIC EVIDENCE Since the ADA first began publishing practice guidelines, there has been con- siderable evolution in the evaluation of scientific evidence and in the develop- ment of evidence-based guidelines. In 2002, the ADA developed a classification system to grade the quality of scientific evidence supporting ADA recommen- dations. A 2015 analysis of the evi- dence cited in the Standards of Care found steady improvement in quality over the previous 10 years, with the 2014 Standards of Care for the first time having the majority of bulleted recommendations supported by A- or B-level evidence (4). A grading system (Table 1) developed by the ADA and modeled after existing methods was used to clarify and codify the evidence that forms the basis for the recommen- dations. ADA recommendations are as- signed ratings of A, B, or C, depending on the quality of evidence. Expert opinion E is a separate category for recommen- dations in which there is no evidence from clinical trials, in which clinical trials may be impractical, or in which there is conflicting evidence. Recommenda- tions with an A rating are based on large well-designed clinical trials or well-done meta-analyses. Generally, these recom- mendations have the best chance of improving outcomes when applied to the population to which they are ap- propriate. Recommendations with lower levels of evidence may be equally im- portant but are not as well supported. Of course, evidence is only one com- ponent of clinical decision making. Clini- cians care for patients, not populations; guidelines must always be interpreted with the individual patient in mind. In- dividualcircumstances,suchascomorbid and coexisting diseases, age, education, disability, and, above all, patients’ values and preferences, must be considered and may lead to different treatment tar- gets and strategies. Furthermore, con- ventional evidence hierarchies, such as the one adapted by the ADA, may miss nuances important in diabetes care. For example, although there is excellent evidence from clinical trials supporting the importance of achieving multiple risk factor control, the optimal way to achieve this result is less clear. It is dif- ficult to assess each component of such a complex intervention. References 1. American Diabetes Association. Medical Management of Type 1 Diabetes. 7th ed. WangCC,ShahAC,Eds.Alexandria,VA,American Diabetes Association, 2017 2. American Diabetes Association. Medical Management of Type 2 Diabetes. 7th ed. Burant CF, Young LA, Eds. Alexandria, VA, American Diabetes Association, 2012 3. Li R, Zhang P, Barker LE, Chowdhury FM, Zhang X. Cost-effectiveness of interventions to prevent and control diabetes mellitus: a sys- tematic review. Diabetes Care 2010;33:1872– 1894 4. Grant RW, Kirkman MS. Trends in the ev- idence level for the American Diabetes As- sociation’s “Standards of Medical Care in Diabetes” from 2005 to 2014. Diabetes Care 2015;38:6–8 Table 1—ADA evidence-grading system for “Standards of Medical Care in Diabetes” Level of evidence Description A Clear evidence from well-conducted, generalizable randomized controlled trials that are adequately powered, including c Evidence from a well-conducted multicenter trial c Evidence from a meta-analysis that incorporated quality ratings in the analysis Compelling nonexperimental evidence, i.e., “all or none” rule developed by the Centre for Evidence-Based Medicine at the University of Oxford Supportive evidence from well-conducted randomized controlled trials that are adequately powered, including c Evidence from a well-conducted trial at one or more institutions c Evidence from a meta-analysis that incorporated quality ratings in the analysis B Supportive evidence from well-conducted cohort studies c Evidence from a well-conducted prospective cohort study or registry c Evidence from a well-conducted meta-analysis of cohort studies Supportive evidence from a well-conducted case-control study C Supportive evidence from poorly controlled or uncontrolled studies c Evidencefromrandomizedclinicaltrialswithoneormoremajororthree or more minor methodological flaws that could invalidate the results c Evidencefromobservationalstudieswithhighpotentialforbias(suchas case series with comparison with historical controls) c Evidence from case series or case reports Conflicting evidence with the weight of evidence supporting the recommendation E Expert consensus or clinical experience S2 Introduction Diabetes Care Volume 42, Supplement 1, January 2019
Professional Practice Committee: Standards of Medical Care in Diabetesd2019 Diabetes Care 2019;42(Suppl. 1):S3| https://doi.org/10.2337/dc19-SPPC01 The Professional Practice Committee (PPC) of the American Diabetes Associ- ation (ADA) is responsible for the “Stan- dards of Medical Care in Diabetes,” referred to as the Standards of Care. The PPC is a multidisciplinary expert committee comprised of physicians, diabetes educators, and others who have expertise in a range of areas, including adult and pediatric endocri- nology, epidemiology, public health, lipid research, hypertension, precon- ception planning, and pregnancy care. Appointment to the PPC is based on excellence in clinical practice and re- search. Although the primary role of the PPC is to review and update the Standards of Care, it may also be in- volved in ADA statements, reports, and reviews. The ADA adheres to the National Academy of Medicine Standards for De- veloping Trustworthy Clinical Practice Guidelines. All members of the PPC are required to disclose potential con- flicts of interest with industry and/or other relevant organizations. These dis- closures are discussed at the onset of each Standards of Care revision meeting. Members of the committee, their em- ployers, and their disclosed conflicts of interest are listed in the “Disclosures: Standards of Medical Care in Diabetesd 2019” table (see pp. S184–S186). The ADA funds development of the Stand- ards of Care out of its general revenues and does not use industry support for this purpose. For the current revision, PPC mem- bers systematically searched MEDLINE for human studies related to each section and published since 15 October 2017. Recommendations were revised based on new evidence or, in some cases, to clarify the prior recommendation or match the strength of the wording to the strength of the evidence. A table linking the changes in recommendations to new evidence can be reviewed at professional.diabetes.org/SOC. The Stan- dards of Care was approved by ADA’s Board of Directors, which includes health careprofessionals,scientists,andlaypeople. Feedback from the larger clinical com- munity was valuable for the 2018 revision of the Standards of Care. Readers who wish to comment on the 2019 Standards of Care are invited to do so at professional .diabetes.org/SOC. The PPC would like to thank the fol- lowing individuals who provided their expertise in reviewing and/or consulting withthecommittee:AnnAlbright,PhD,RD; Pamela Allweiss, MD, MPH; Barbara J. Anderson, PhD; George Bakris, MD; Richard Bergenstal, MD; Stuart Brink, MD; Donald R. Coustan, MD; Ellen D. Davis, MS, RN, CDE, FAADE; Jesse Dinh, PharmD; Steven Edelman, MD;BarryH.Ginsberg, MD, PhD; Irl B. Hirsch, MD; Scott Kahan, MD, MPH; David Klonoff, MD; Joyce Lee, MD, MPH; Randie Little, PhD; Alexandra Migdal, MD; Anne Peters, MD; Amy Rothberg, MD; Jennifer Sherr, MD, PhD; Hood Thabit, MB, BCh, MD, PhD; Stuart AlanWeinzimer, MD; and Neil White, MD. Members of the PPC Joshua J. Neumiller, PharmD, CDE, FASCP* (Chair) Christopher P. Cannon, MD Jill Crandall, MD David D’Alessio, MD Ian H. de Boer, MD, MS* Mary de Groot, PhD Judith Fradkin, MD Kathryn Evans Kreider, DNP, APRN, FNP-BC, BC-ADM David Maahs, MD, PhD Nisa Maruthur, MD, MHS Medha N. Munshi, MD* Maria Jose Redondo, MD, PhD, MPH Guillermo E. Umpierrez, MD, CDE, FACE, FACP* Jennifer Wyckoff, MD *Subgroup leaders ADA Nutrition Consensus Report Writing GroupdLiaison Melinda Maryniuk, MEd, RDN, CDE American College of CardiologydDesignated Representatives (Section 10) Sandeep Das, MD, MPH, FACC Mikhail Kosiborod, MD, FACC ADA Staff Erika Gebel Berg, PhD (correspondingauthor:eberg@diabetes.org) Mindy Saraco, MHA Matthew P. Petersen Sacha Uelmen, RDN, CDE Shamera Robinson, MPH, RDN William T. Cefalu, MD © 2018 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license. Diabetes Care Volume 42, Supplement 1, January 2019 S3 PROFESSIONALPRACTICECOMMITTEE
Summary of Revisions: Standards of Medical Care in Diabetesd2019 Diabetes Care 2019;42(Suppl. 1):S4–S6 | https://doi.org/10.2337/dc19-srev01 GENERAL CHANGES The field of diabetes care is rapidly changing as new research, technology, and treatments that can improve the health and well-being of people with diabetes continue to emerge. With an- nual updates since 1989, the American Diabetes Association (ADA) has long been a leader in producing guidelines that capture the most current state of the field. To that end, the “Standards of Medical Care in Diabetes” (Standards ofCare)nowincludesadedicatedsection on Diabetes Technology, which contains preexisting material that was previously in other sections that has been consol- idated,aswellasnew recommendations. Another general change is that each rec- ommendation is now associated with a number (i.e., the second recommendation in Section 7 is now recommendation 7.2). Finally, the order of the prevention section was changed (from Section 5 to Section 3) to follow a more logical progression. Although levels of evidence for several recommendations have been updated, these changes are not addressed below as the clinical recommendations have remained the same. Changes in evidence level from, for example, E to C are not noted below. The 2019 Standards of Care contains, in addition to many minor changes that clarify recommendations or reflect new evidence, the following more substantive revisions. SECTION CHANGES Section 1. Improving Care and Promoting Health in Populations Additional information was included on the financial costs of diabetes to individ- uals and society. Because telemedicine is a growing field that may increase access to care forpatientswithdiabetes,discussionwas added on its use to facilitate remote delivery of health-related services and clinical information. Section 2. Classification and Diagnosis of Diabetes Based on new data, the criteria for the diagnosis of diabetes was changed to include two abnormal test results from the same sample (i.e., fasting plasma glucose and A1C from same sample). The section was reorganized to im- prove flow and reduce redundancy. Additional conditions were identified that may affect A1C test accuracy including the postpartum period. Section 3. Prevention or Delay of Type 2 Diabetes This section was moved (previously it was Section 5) and is now located before the Lifestyle Management section to better reflect the progression of type 2 diabetes. The nutrition section was updated to highlight the importance of weight loss for those at high risk for developing type 2 diabetes who have overweight or obesity. Because smoking may increase the risk of type 2 diabetes, a section on tobacco use and cessation was added. Section 4. Comprehensive Medical Evaluation and Assessment of Comorbidities On the basis of a new consensus report on diabetes and language, new text was added to guide health care professionals’ use of language to communicate about diabetes with people with diabetes and professional audiences inan informative, empowering, and educational style. A new figure from the ADA-European Association for the Study of Diabetes (EASD) consensus report about the di- abetes care decision cycle was added to emphasize the need for ongoing assess- ment and shared decision making to achieve the goals of health care and avoid clinical inertia. A new recommendation was added to explicitly call out the importance of the diabetes care team and to list the pro- fessionals that make up the team. The table listing the components of a comprehensive medical evaluation was revised, and the section on assessment and planning was used to create a new table (Table 4.2). A new table was added listing factors that increase risk of treatment-associated hypoglycemia (Table 4.3). A recommendation was added to in- clude the 10-year atherosclerotic cardio- vascular disease (ASCVD) risk as part of overall risk assessment. The fatty liver disease section was revised to include updated text and a new recommendation regarding when to test for liver disease. Section 5. Lifestyle Management Evidence continues to suggest that there is not an ideal percentage of calories from carbohydrate, protein, and fat for all people with diabetes. Therefore, more discussion was added about the im- portance of macronutrient distribution based on an individualized assessment of currenteatingpatterns,preferences,and metabolic goals. Additional considera- tions were added to the eating © 2018 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license. S4 Diabetes Care Volume 42, Supplement 1, January 2019 SUMMARYOFREVISIONS
patterns, macronutrient distribution, and meal planning sections to better iden- tify candidates for meal plans, specifically for low-carbohydrate eating patterns and people who are pregnant or lactat- ing, who have or are at risk for disor- dered eating, who have renal disease, and who are taking sodium–glucose co- transporter 2 inhibitors. There is not a one-size-fits-all eating pattern for in- dividuals with diabetes, and meal plan- ning should be individualized. A recommendation was modified to encourage people with diabetes to de- crease consumption of both sugar sweetened and nonnutritive-sweetened beverages and use other alternatives, with an emphasis on water intake. The sodium consumption recommen- dation was modified to eliminate the further restriction that was potentially indicated for those with both diabetes and hypertension. Additional discussion was added to the physical activity section to include the ben- efit of a variety of leisure-time physical ac- tivities and flexibility and balance exercises. The discussion about e-cigarettes was expanded to include more on public perception and how their use to aide smoking cessation was not more effec- tive than “usual care.” Section 6. Glycemic Targets This section now begins with a discussion of A1C tests to highlight the centrality of A1C testing in glycemic management. The self-monitoring of blood glucose and continuous glucose monitoring text and recommendations were moved to the new Diabetes Technology section. To emphasize that the risks and ben- efits of glycemic targets can change as diabetes progresses and patients age, a recommendation was added to reeval- uate glycemic targets over time. The section was modified to align with the living Standards updates made in April 2018 regarding the consensus definition of hypoglycemia. Section 7. Diabetes Technology This new section includes new recommen- dations, the self-monitoring of blood glu- cose section formerly included in Section 6 “Glycemic Targets,” and a discussion of insulindeliverydevices(syringes,pens,and insulin pumps), blood glucose meters, con- tinuous glucose monitors (real-time and intermittently scanned [“flash”]), and au- tomated insulin delivery devices. The recommendation to use self- monitoring of blood glucose in people who are not using insulin was changed to acknowledge that routine glucose monitoring is of limited additional clin- ical benefit in this population. Section 8. Obesity Management for the Treatment of Type 2 Diabetes A recommendation was modified to acknowledge the benefits of tracking weight, activity, etc., in the context of achieving and maintaining a healthy weight. A brief section was added on medical devices for weight loss, which are not currently recommended due to limited data in people with diabetes. The recommendations for metabolic surgery were modified to align with re- cent guidelines, citing the importance of considering comorbidities beyond dia- betes when contemplating the ap- propriateness of metabolic surgery for a given patient. Section 9. Pharmacologic Approaches to Glycemic Treatment The section on the pharmacologic treat- ment of type 2 diabetes was signifi- cantly changed to align, as per the living Standards update in October 2018, with the ADA-EASD consensus report on this topic, summarized in the new Figs. 9.1 and 9.2. This includes consideration of key patient factors: a) important comorbidities such as ASCVD, chronic kidney disease, and heart failure, b) hypoglycemia risk, c) effects on body weight, d) side effects, e) costs, and f) patient preferences. To align with the ADA-EASD con- sensus report, the approach to inject- able medication therapy was revised (Fig. 9.2). A recommendation that, for most patients who need the greater efficacy of an injectable medication, a glucagon-like peptide 1 receptor ago- nist should be the first choice, ahead of insulin. A new section was added on insulin injection technique, emphasizing the im- portance of technique for appropriate insulin dosing and the avoidance of com- plications (lipodystrophy, etc.). The section on noninsulin pharmaco- logic treatments for type 1 diabetes was abbreviated, as these are not generally recommended. Section 10. Cardiovascular Disease and Risk Management For the first time, this section is endorsed by the American College of Cardiology. Additional text was added to acknowl- edge heart failure as an important type of cardiovascular disease in people with diabetes for consideration when deter- mining optimal diabetes care. The blood pressure recommenda- tions were modified to emphasize the importance of individualization of targets based on cardiovascular risk. A discussion of the appropriate use of the ASCVD risk calculator was included, and recommendations were modified to include assessment of 10-year ASCVD risk as part of overall risk assessment and in determining optimal treatment approaches. The recommendation and text regard- ing the use of aspirin in primary pre- vention was updated with new data. For alignment with the ADA-EASD consensusreport, two recommendations were added for the use of medications thathaveprovencardiovascularbenefitin people with ASCVD, with and without heart failure. Section 11. Microvascular Complications and Foot Care To align with the ADA-EASD consensus report, a recommendation was added for people with type 2 diabetes and chronic kidney disease to consider agents with proven benefit with regard to renal out- comes. The recommendation on the use of telemedicine in retinal screening was modified to acknowledge the utility of this approach, so long as appropriate referrals are made for a comprehensive eye examination. Gabapentin was added to the list of agents to be considered for the treat- ment of neuropathic pain in people with diabetes based on data on efficacy and the potential for cost savings. The gastroparesis section includes a discussion of a few additional treatment modalities. The recommendation for patients with diabetes to have their feet inspected at every visit was modified to only include those at high risk for ulceration. Annual care.diabetesjournals.org Summary of Revisions S5
examinations remain recommended for everyone. Section 12. Older Adults A new section and recommendation on lifestyle management was added to address the unique nutritional and physical activity needs and considerations for older adults. Within the pharmacologic therapy discussion, deintensification of insulin re- gimes was introduced to help simplify insulin regimen to match individual’s self-management abilities. A new figure was added (Fig. 12.1) that provides a path for simplification. A new table was also added (Table 12.2) to help guide providers considering medication regimen simplifi- cation and deintensification/deprescrib- ing in older adults with diabetes. Section 13. Children and Adolescents Introductory language was added to the beginning of this section reminding the reader that the epidemiology, patho- physiology, developmental consider- ations, and response to therapy in pediatric-onset diabetes are different from adult diabetes, and that there are also differences in recommended care for children and adolescents with type 1 as opposed to type 2 diabetes. A recommendation was added to em- phasize the need for disordered eating screening in youth with type 1 diabetes beginning at 10–12 years of age. Based on new evidence, a recom- mendation was added discouraging e-cigarette use in youth. The discussion of type 2 diabetes in children and adolescents was significantly expanded, with new recommendations in a number of areas, including screen- ing and diagnosis, lifestyle management, pharmacologic management, and transi- tion of care to adult providers. New sections and/or recommendations for type 2 diabetes in children and adoles- cents were added for glycemic targets, metabolic surgery, nephropathy, neurop- athy, retinopathy, nonalcoholic fatty liver disease, obstructive sleep apnea, poly- cystic ovary syndrome, cardiovascular disease, dyslipidemia, cardiac function testing, and psychosocial factors. Figure 13.1 was added to provide guidance on the management of diabetes in overweight youth. Section 14. Management of Diabetes in Pregnancy Women with preexisting diabetes are now recommended to have their care managed in a multidisciplinary clinic to improve diabetes and pregnancy out- comes. Greater emphasis has been placed on the use of insulin as the preferred med- ication for treating hyperglycemia in gestational diabetes mellitus as it does not cross the placenta to a measurable extent and how metformin and gly- buride should not be used as first- line agents as both cross the placenta to the fetus. Section 15. Diabetes Care in the Hospital Because of their ability to improve hos- pital readmission rates and cost of care, a new recommendation was added call- ing for providers to consider consulting with a specialized diabetes or glucose management team where possible when caring for hospitalized patients with diabetes. Section 16. Diabetes Advocacy The “Insulin Access and Affordability Working Group: Conclusions and Recommendations” ADA statement was added to this section. Published in 2018, this statement compiled public informa- tion and convened a series of meetings with stakeholders throughout the in- sulin supply chain to learn how each entity affects the cost of insulin for the consumer, an important topic for the ADA and people living with diabetes. S6 Summary of Revisions Diabetes Care Volume 42, Supplement 1, January 2019
1. Improving Care and Promoting Health in Populations: Standards of Medical Care in Diabetesd2019 Diabetes Care 2019;42(Suppl. 1):S7–S12 | https://doi.org/10.2337/dc19-S001 The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes” includes ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations, please refer to the Standards of Care Introduction. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC. DIABETES AND POPULATION HEALTH Recommendations 1.1 Ensure treatment decisions are timely, rely on evidence-based guidelines, and are made collaboratively with patients based on individual preferences, prog- noses, and comorbidities. B 1.2 Align approaches to diabetes management with the Chronic Care Model, emphasizing productive interactions between a prepared proactive care team and an informed activated patient. A 1.3 Care systems should facilitate team-based care, patient registries, decision support tools, and community involvement to meet patient needs. B 1.4 Efforts to assess the quality of diabetes care and create quality improvement strategies should incorporate reliable data metrics, to promote improved pro- cesses of care and health outcomes, with simultaneous emphasis on costs. E Population health is defined as “the health outcomes of a group of individuals, including the distribution of health outcomes within the group”; these outcomes can bemeasuredintermsofhealthoutcomes(mortality,morbidity,health,andfunctional status), disease burden (incidence and prevalence), and behavioral and metabolic factors(exercise,diet,A1C,etc.)(1).Clinicalpracticerecommendationsforhealthcare providers are tools that can ultimately improve health across populations; however, for optimal outcomes, diabetes care must also be individualized for each patient. Thus, efforts to improve population health will require a combination of system-level and patient-level approaches. With such an integrated approach in mind, the American Diabetes Association (ADA) highlights the importance of patient-centered care, defined as care that is respectful of and responsive to individual patient preferences, needs, and values and that ensures that patient values guide all clinical decisions (2). Clinical practice recommendations, whether based on evidence or expert opinion, are Suggested citation: American Diabetes Associa- tion. 1. Improving care and promoting health in populations: Standards of Medical Care in Diabetesd2019. Diabetes Care 2019;42(Suppl. 1): S7–S12 © 2018 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More infor- mation is available at http://www.diabetesjournals .org/content/license. American Diabetes Association Diabetes Care Volume 42, Supplement 1, January 2019 S7 1.IMPROVINGCAREANDPROMOTINGHEALTH
intended to guide an overall approach to care. The science and art of medicine come together when the clinician is faced with making treatment recommenda- tions for a patient who may not meet the eligibility criteria used in the studies on which guidelines are based. Recog- nizing that one size does not fit all, the standards presented here provide guid- ance for when and how to adapt rec- ommendations for an individual. Care Delivery Systems The proportion of patients with diabetes who achieve recommended A1C, blood pressure, and LDL cholesterol levels has increased in recent years (3). The mean A1C nationally among people with diabe- tes declined from 7.6% (60 mmol/mol) in 1999–2002 to 7.2% (55 mmol/mol) in 2007–2010 based on the National Health and Nutrition Examination Survey (NHANES), with younger adults less likely to meet treatment targets than older adults (3). This has been accompanied by improvements in cardiovascular out- comes and has led to substantial re- ductions in end-stage microvascular complications. Nevertheless, 33–49% of patients still did not meet general targets for glyce- mic, blood pressure, or cholesterol con- trol, and only 14% met targets for all three measures while also avoiding smok- ing(3).Evidencesuggests that progress in cardiovascular risk factor control (partic- ularly tobacco use) may be slowing (3,4). Certain segments of the population, such asyoungadultsandpatientswithcomplex comorbidities, financial or other social hardships, and/or limited English pro- ficiency, face particular challenges to goal-based care (5–7). Even after adjust- ing for these patient factors, the persis- tent variability in the quality of diabetes care across providers and practice set- tings indicates that substantial system- level improvements are still needed. Diabetes poses a significant financial burden to individuals and society. It is estimated that the annual cost of di- agnosed diabetes in 2017 was $327 billion, including $237 billion in direct medical costs and $90 billion in reduced productivity. After adjusting for inflation, economic costs of diabetes increased by 26% from 2012 to 2017 (8). This is attributed to the increased prevalence of diabetes and the increased cost per person with diabetes. Ongoing population health strategies are needed in order to reduce costs and provide optimized care. Chronic Care Model Numerous interventions to improve ad- herence to the recommended standards have been implemented. However, a major barrier to optimal care is a delivery system that is often fragmented, lacks clinical information capabilities, dupli- cates services, and is poorly designed for the coordinated delivery of chronic care. The Chronic Care Model (CCM) takes these factors into consideration and is an effective framework for im- proving the quality of diabetes care (9). Six Core Elements. The CCM includes six core elements to optimize the care of patients with chronic disease: 1. Delivery system design (moving from a reactive to a proactive care delivery system where planned visits are coordinated through a team-based approach) 2. Self-management support 3. Decision support (basing care on evidence-based, effective care guidelines) 4. Clinical information systems (using registries that can provide patient- specific and population-based sup- port to the care team) 5. Community resources and policies (identifying or developing resources to support healthy lifestyles) 6. Health systems (to create a quality- oriented culture) Redefining the roles of the health care delivery team and empowering patient self-management are fundamental to the successful implementation of the CCM (10). Collaborative, multidisciplinary teams are best suited to provide care for people with chronic conditions such as diabetes and to facilitate patients’ self-management (11–13). Strategies for System-Level Improvement Optimal diabetes management requires an organized, systematic approach and the involvement of a coordinated team of dedicated health care professionals work- ing in an environment where patient- centered high-quality care is a priority (7,14,15). While many diabetes pro- cesses of care have improved nationally in the past decade, the overall quality of care for patients with diabetes remains suboptimal (3). Efforts to increase the quality of diabetes care include provid- ing care that is concordant with evidence-based guidelines (16); expand- ing the role of teams to implement more intensive disease management strate- gies (7,17,18); tracking medication- taking behavior at a systems level (19); redesigning the organization of the care process (20); implementing electronic health record tools (21,22); empowering and educating patients (23,24); removing financial barriers and reducing patient out-of-pocket costs for diabetes educa- tion, eye exams,diabetes technology,and necessary medications (7); assessing and addressing psychosocial issues (25,26); and identifying, developing, and engaging community resources and public policies that support healthy lifestyles (27). The National Diabetes Education Program maintains an online resource (www .betterdiabetescare.nih.gov)tohelphealth care professionals design and implement moreeffectivehealthcaredeliverysystems for those with diabetes. The care team, which centers around the patient, should avoid therapeutic inertia and prioritize timely and appro- priate intensification of lifestyle and/or pharmacologic therapy for patients who have not achieved the recommended metabolic targets (28–30). Strategies shown to improve care team behavior and thereby catalyze reductions in A1C, blood pressure, and/or LDL cholesterol include engaging in explicit and collab- orative goal setting with patients (31,32); identifying and addressing language, numeracy, or cultural barriers to care (33–35); integrating evidence-based guide- lines and clinical information tools into the process of care (16,36,37); soliciting performance feedback, setting reminders, and providing structured care (e.g., guidelines, formal case manage- ment, and patient education resources) (7); and incorporating care management teams including nurses, dietitians, phar- macists, and other providers (17,38). Initiatives such as the Patient-Centered Medical Home show promise for im- proving health outcomes by fostering comprehensive primary care and offer- ing new opportunities for team-based chronic disease management (39). Telemedicine is a growing field that may increase access to care for patients with diabetes. Telemedicine is defined as the use of telecommunications to S8 Improving Care and Promoting Health Diabetes Care Volume 42, Supplement 1, January 2019
facilitate remote delivery of health-re- lated services and clinical information (40). A growing body of evidence sug- gests that various telemedicine modali- ties may be effective at reducing A1C in patients with type 2 diabetes compared with usual care or in addition to usual care (41). For rural populations or those with limited physical access to health care, telemedicine has a growing body of evidenceforits effectiveness, particularly with regard to glycemic control as mea- sured by A1C (42–44). Interactive strat- egies that facilitate communication between providersandpatients,including the use of web-based portals or text messaging and those that incorporate medication adjustment, appear more effective. There is limited data avail- able on the cost-effectiveness of these strategies. Successful diabetes care also requires a systematic approach to supporting patients’ behavior change efforts. High-quality diabetes self-management education and support (DSMES) has been shown to improve patient self- management, satisfaction, and glucose outcomes. National DSMES standards call for an integrated approach that in- cludes clinical content and skills, behav- ioral strategies (goal setting, problem solving), and engagement with psycho- social concerns (26). For more informa- tion on DSMES, see Section 5 “Lifestyle Management.” In devising approaches to support disease self-management, it is notable that in 23% of cases, uncontrolled A1C, blood pressure, or lipids were associated with poor medication-taking behaviors (“medication adherence”) (19). At a sys- tem level, “adequate” medication taking is defined as 80% (calculated as the number of pills taken by the patient in a given time period divided by the number of pills prescribed by the physi- cian in that same time period) (19). If medication taking is 80% or above and treatment goals are not met, then treatment intensification should be considered (e.g., uptitration). Barriers to medication taking may include patient factors (financial limitations, remembering to obtain or take medica- tions, fear, depression, or health beliefs), medication factors (complexity, multiple daily dosing, cost, or side effects), and system factors (inadequate follow- up or support). Success in overcoming barriers to medication taking may be achieved if the patient and provider agree on a targeted approach for a spe- cific barrier (12). The Affordable Care Act has resulted in increased access to care for many individuals with diabetes with an empha- sis on the protection of people with preexisting conditions, health promotion, anddiseaseprevention(45).Infact,health insurance coverage increased from 84.7% in 2009 to 90.1% in 2016 for adults with diabetes aged 18–64 years. Coverage for those $65 years remained near universal (46). Patients who have eitherprivate orpublicinsurance coverage are more likely to meet quality indicators for diabetes care (47). As mandated by the Affordable Care Act, the Agency for Healthcare Research and Quality developed a National Quality Strategy based on the triple aims that include improving the health of a population, overall quality and patient experience of care, and per capita cost (48,49). As health care systems and practices adapt to the changing landscape of health care, it will be important to integrate traditional disease-specific metrics with measures of patient experience, as well as cost, in assessing the quality of diabe- tes care (50,51). Information and guid- ance specific to quality improvement and practice transformation for diabetes care is available from the National Diabetes Education Program practice transforma- tion website and the National Institute of Diabetes and Digestive and Kidney Dis- eases report on diabetes care and quality (52,53). Using patient registries and elec- tronic health records, health systems can evaluate the quality of diabetes care being delivered and perform interven- tion cycles as part of quality improve- ment strategies (54). Critical to these efforts is provider adherence to clinical practice recommendations and accu- rate, reliable data metrics that include sociodemographic variables to examine health equity within and across popula- tions (55). In addition to quality improvement efforts, other strategies that simulta- neously improve the quality of care and potentially reduce costs are gaining momentum and include reimbursement structures that, in contrast to visit-based billing, reward the provision of appro- priate and high-quality care to achieve metabolic goals (56) and incentives that accommodate personalized care goals (7,57). TAILORING TREATMENT FOR SOCIAL CONTEXT Recommendations 1.5 Providers should assess social context, including potential food insecurity, housing stabil- ity, and financial barriers, and apply that information to treat- ment decisions. A 1.6 Refer patients to local commu- nity resources when available. B 1.7 Provide patients with self- management support from lay health coaches, navigators, or community health workers when available. A Health inequities related to diabetes and its complications are well docu- mented and are heavily influenced by social determinants of health (58–62). Socialdeterminants ofhealtharedefined as the economic, environmental, politi- cal, and social conditions in which people live and are responsible for a major part of health inequality worldwide (63). The ADA recognizes the association between social and environmental factors and the prevention and treatment of diabetes and has issued a call for research that seeks to better understand how these social determinants influence behaviors and how the relationships between these variables might be modified for the pre- vention and management of diabetes (64). While a comprehensive strategy to reduce diabetes-related health inequi- ties in populations has not been for- mally studied, general recommendations from other chronic disease models can be drawn upon to inform systems-level strategies in diabetes. For example, the National Academy of Medicine has published a framework for educating health care professionals on the impor- tance of social determinants of health (65). Furthermore, there are resources available for the inclusion of standard- ized sociodemographic variables in elec- tronic medical records to facilitate the measurement of health inequities as well as the impact of interventions de- signed toreducethose inequities(66–68). Social determinants of health are not always recognized and often go undis- cussed in the clinical encounter (61). A care.diabetesjournals.org Improving Care and Promoting Health S9
study by Piette et al. (69) found that among patients with chronic illnesses, two-thirds of those who reported not taking medications as prescribed due to cost never shared this with their physi- cian. In a more recent study using data from the National Health Interview Survey (NHIS), Patel et al. (61) found that half of adults with diabetes reported financial stress and one-fifth reported food insecurity (FI). One population in which such issues must be considered is olderadults,where socialdifficultiesmay impair their quality of life and increase their risk of functional dependency (70) (see Section 12 “Older Adults” for a de- tailed discussion of social considerations in older adults). Creating systems-level mechanisms to screen for social deter- minants of health may help overcome structural barriers and communication gaps between patients and providers (61). In addition, brief, validated screen- ing tools for some social determinants of health exist and could facilitate discus- sion around factors that significantly impact treatment during the clinical en- counter. Below is a discussion of assess- ment and treatment considerations in the context of FI, homelessness, and limited English proficiency/low literacy. Food Insecurity FI is the unreliable availability of nutri- tious food and the inability to consis- tently obtain food without resorting to socially unacceptable practices. Over 14% (or one of every seven people) of the U.S. population is food insecure. The rate is higher in some racial/ethnic minority groups, including African American and Latino populations, in low-income households, and in homes headed by a single mother. The risk for type 2 diabetes is increased twofold in those with FI (64) and has been associ- ated with low adherence to taking medi- cations appropriately and recommended self-care behaviors, depression, diabe- tes distress, and worse glycemic control when compared with individuals who are food secure (71,72). Risk for FI can be assessed with a validated two-item screening tool (73) that includes the statements: 1) “Within the past 12 months we worried whether our food would run out before we got money to buy more” and 2) “Within the past 12 months the food we bought just didn’t last and we didn’t have money to get more.” An affirmative response to either statement had a sensitivity of 97% and specificity of 83%. Treatment Considerations In those with diabetes and FI, the priority is mitigating the increased risk for un- controlled hyperglycemia and severe hy- poglycemia. Reasons for the increased risk of hyperglycemia include the steady consumption of inexpensive carbohy- drate-rich processed foods, binge eat- ing, financial constraints to the filling of diabetes medication prescriptions, and anxiety/depression leading to poor diabetes self-care behaviors. Hypoglyce- mia can occur as a result of inadequate or erratic carbohydrate consumption following the administration of sul- fonylureas or insulin. See Table 9.1 for drug-specific and patient factors, includ- ing cost and risk of hypoglycemia, for treatment options for adults with FI and type 2 diabetes. Providers should con- sider these factors when making treat- ment decisions in people with FI and seek local resources that might help patients with diabetes and their family members to more regularly obtain nutritious food (74). Homelessness Homelessness often accompanies many additional barriers to diabetes self- management, including FI, literacy and numeracy deficiencies, lack of insurance, cognitive dysfunction, and mental health issues. Additionally, patients with diabe- tes who are homeless need secure places to keep their diabetes supplies and re- frigerator access to properly store their insulin and take it on a regular schedule. Risk for homelessness can be ascertained using a brief risk assessment tool de- veloped and validated for use among veterans (75). Given the potential chal- lenges, providers who care for homeless individuals should be familiar with re- sources or have access to social workers that can facilitate temporary housing for their patients as a way to improve diabetes care. Language Barriers Providers who care for non-English speakers should develop or offer educa- tional programs and materials in multiple languages with the specific goals of pre- venting diabetes and building diabetes awareness in people who cannot easily read or write in English. The National Standards for Culturally and Linguisti- cally Appropriate Services in Health and Health Care provide guidance on how health care providers can reduce language barriers by improving their cultural competency, addressing health literacy, and ensuring communication with language assistance (76). The site offers a number of resources and materi- als that can be used to improve the quality of care delivery to non-English–speaking patients. Community Support Identification or development of com- munity resources to support healthy lifestyles is a core element of the CCM (9). Health care community linkages are receiving increasing attention from the American Medical Association, the Agency for Healthcare Research and Quality, and others as a means of pro- moting translation of clinical recommen- dations for lifestyle modification in real- world settings (77). Community health workers (CHWs) (78), peer supporters (79–81), and lay leaders (82) may assist in the delivery of DSMES services (66), particularly in underserved communi- ties. A CHW is defined by the American Public Health Association as a “frontline public health worker who is a trusted member of and/or has an unusually close understanding of the community served” (83). CHWs can be part of a cost-effective, evidence-based strategy to improve the management of diabetes and car- diovascular risk factors in underserved communities and health care systems (84). References 1. Kindig D, Stoddart G. What is population health? Am J Public Health 2003;93:380–383 2. 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Casagrande SS, McEwen LN, Herman WH. Changes in health insurance coverage under the Affordable Care Act: a national sample of U.S. adults with diabetes, 2009 and 2016. Diabetes Care 2018;41:956–962 47. Doucette ED, Salas J, Scherrer JF. Insurance coverage and diabetes quality indicators among patients in NHANES. Am J Manag Care 2016;22: 484–490 48. Stiefel M, Nolan K. Measuring the triple aim: a call for action. Popul Health Manag 2013;16: 219–220 49. Agency for Healthcare Researchand Quality. About the National Quality Strategy [Internet], 2017. Available from https://www.ahrq.gov/ workingforquality/about/index.html. Accessed 22 October 2018 50. National Quality Forum. Home page [Internet], 2017. Available from http://www.qualityforum .org/home.aspx. Accessed 22 October 2018 51. Burstin H, Johnson K. Getting to better care and outcomes for diabetes through measure- ment [article online], 2016. Available from http://www.ajmc.com/journals/evidence-based- diabetes-management/2016/march-2016/getting- to-better-care-and-outcomes-for-diabetes-through- measurement. Accessed 22 October 2018 52. National Institute of Diabetes and Diges- tive and Kidney Diseases. Practice transformation for physicians & health care teams [Internet]. Available from https://www.niddk.nih.gov/ health-information/health-communication- programs/ndep/health-care-professionals/ practice-transformation/Pages/resourcedetail .aspx. Accessed 22 October 2018 care.diabetesjournals.org Improving Care and Promoting Health S11
53. National Institute of Diabetes and Digestive and Kidney Diseases. Diabetes care and quality: past,present,andfuture[Internet].Availablefrom https://www.niddk.nih.gov/health-information/ health-communication-programs/ndep/health- care-professionals/practice-transformation/ defining-quality-care/diabetes-care-quality/Pages/ default.aspx. Accessed 22 October 2018 54. O’Connor PJ, Sperl-Hillen JM, Fazio CJ, Averbeck BM, Rank BH, Margolis KL. Outpatient diabetes clinical decision support: current status and future directions. Diabet Med 2016;33:734–741 55. Centers for Medicare & Medicaid Services. CMS Equity Plan for Medicare [Internet]. Avail- able from https://www.cms.gov/About-CMS/ Agency-Information/OMH/equity-initiatives/ equity-plan.html. Accessed 22 October 2018 56. Rosenthal MB, Cutler DM, Feder J. The ACO rules–striking the balance betweenparticipation and transformative potential. N Engl J Med 2011;365:e6 57. Washington AE, Lipstein SH. The Patient- Centered Outcomes Research Institute–promoting better information, decisions, and health. N Engl J Med 2011;365:e31 58. Hutchinson RN, Shin S. Systematic review of health disparities for cardiovascular diseasesand associated factors among American Indian and Alaska Native populations. PLoS One 2014;9: e80973 59. Borschuk AP, Everhart RS. Health disparities among youth with type 1 diabetes: a systematic review of the current literature. Fam Syst Health 2015;33:297–313 60. Walker RJ, Strom Williams J, Egede LE. In- fluenceofrace,ethnicityandsocialdeterminants of health on diabetes outcomes. Am J Med Sci 2016;351:366–373 61. Patel MR, Piette JD, Resnicow K, Kowalski- Dobson T, Heisler M. Social determinants of health, cost-related nonadherence, and cost- reducing behaviors among adults with diabetes: findings from the National Health Interview Survey. Med Care 2016;54:796–803 62. Steve SL, Tung EL, Schlichtman JJ, Peek ME. Social disorder in adults with type 2 diabetes: building on race, place, and poverty. Curr Diab Rep 2016;16:72 63. World Health Organization Commission on Social Determinants of Health. Closing the gap in a generation: health equity through action on the social determinants of health [Internet], 2008. Geneva, Switzerland, World Health Organiza- tion. Available from http://www.who.int/social_ determinants/final_report/csdh_finalreport_2008 .pdf. Accessed 22 October 2018 64. Hill JO, Galloway JM, Goley A, et al. Socio- ecological determinants of prediabetes and type 2 diabetes. Diabetes Care 2013;36:2430– 2439 65. National Academies of Sciences, Engineer- ing, and Medicine. A Framework to Address the Social Determinants of Health [Internet], 2016. Washington, DC, The National Academies Press. Available from https://www.nap.edu/ catalog/21923/a-framework-for-educating-health- professionals-to-address-the-social-determinants- of-health. Accessed 22 October 2018 66. Institute of Medicine. Capturing social and behavioral domains and measures in electronic health records: phase 2 [Internet], 2014. Wash- ington, DC, The National Academies Press. Avail- ablefromhttps://www.nap.edu/catalog/18951/ capturing-social-and-behavioral-domains-and- measures-in-electronic-health-records. Accessed 22 October 2018 67. Chin MH, Clarke AR, Nocon RS, et al. A roadmap and best practices for organizations to reduce racial and ethnic disparities in health care. J Gen Intern Med 2012;27:992–1000 68. National Quality Forum. National voluntary consensus standards for ambulatory cared measuring healthcare disparities [Internet], 2008. Available from https://www.qualityforum.org/ Publications/2008/03/National_Voluntary_ Consensus_Standards_for_Ambulatory_Care% E2%80%94Measuring_Healthcare_Disparities .aspx. Accessed 22 October 2018 69. Piette JD, Heisler M, Wagner TH. Cost- related medication underuse among chronically ill adults: the treatments people forgo, how often, and who is at risk. Am J Public Health 2004;94:1782–1787 70. Laiteerapong N, Karter AJ, Liu JY, et al. Correlates of quality of life in older adults with diabetes: the Diabetes & Aging Study. Di- abetes Care 2011;34:1749–1753 71. Heerman WJ, Wallston KA, Osborn CY, et al. Food insecurity is associated with diabetes self- care behaviours and glycaemic control. Diabet Med 2016;33:844–850 72. Silverman J, Krieger J, Kiefer M, Hebert P, Robinson J, Nelson K. The relationship between food insecurity and depression, diabetes distress and medication adherence among low-income patients with poorly-controlled diabetes. J Gen Intern Med 2015;30:1476–1480 73. Hager ER, Quigg AM, Black MM, et al. De- velopment and validity of a 2-item screen to identify families at risk for food insecurity. Pe- diatrics 2010;126:e26–e32 74. Seligman HK, Schillinger D. Hunger and socioeconomic disparities in chronic disease. N Engl J Med 2010;363:6–9 75. Montgomery AE, Fargo JD, Kane V, Culhane DP. Development and validation of an instrument to assess imminent risk of homelessness among veterans. Public Health Rep 2014;129:428–436 76. U.S. Department of Health and Human Ser- vices. Think cultural health [Internet]. Available from https://www.thinkculturalhealth.hhs.gov/. Accessed 22 October 2018 77. Agency for Healthcare Researchand Quality. Clinical-community linkages [Internet]. Avail- able from http://www.ahrq.gov/professionals/ prevention-chronic-care/improve/community/ index.html. Accessed 22 October 2018 78. Shah M, Kaselitz E, Heisler M. The role of community health workers in diabetes: update on currentliterature.CurrDiabRep2013;13:163–171 79. Heisler M, Vijan S, Makki F, Piette JD. Di- abetes control with reciprocal peer support versus nurse care management: a randomized trial. Ann Intern Med 2010;153:507–515 80. Long JA, Jahnle EC, Richardson DM, Loewenstein G, Volpp KG. Peer mentoring and financial incentives to improve glucose control in African American veterans: a random- ized trial. Ann Intern Med 2012;156:416–424 81. Fisher EB, Boothroyd RI, Elstad EA, et al. Peer support of complex health behaviors in preven- tion and disease management with special ref- erence to diabetes: systematic reviews. Clin Diabetes Endocrinol 2017;3:4 82. Foster G, Taylor SJC, Eldridge SE, Ramsay J, Griffiths CJ. Self-management education pro- grammes by lay leaders for people with chronic conditions. Cochrane Database Syst Rev 2007;4: CD005108 83. Rosenthal EL, Rush CH, Allen CG; Project on CHW Policy & Practice. Understanding scope and competencies: a contemporary look at the United States community health worker field: progress report of the Community Health Worker (CHW) Core Consensus (C3) Project: building national consensus on CHW core roles, skills, and qualities [Internet], 2016. Available from http://files.ctctcdn.com/a907c850501/1c1289f0- 88cc-49c3-a238-66def942c147.pdf. Accessed 22 October 2018 84. U.S. Department of Health and Human Ser- vices. Community health workers help patients manage diabetes [Internet]. Available from https://www.thecommunityguide.org/content/ community-health-workers-help-patients-manage- diabetes. Accessed 22 October 2018 S12 Improving Care and Promoting Health Diabetes Care Volume 42, Supplement 1, January 2019
2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetesd2019 Diabetes Care 2019;42(Suppl. 1):S13–S28 | https://doi.org/10.2337/dc19-S002 The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes” includes ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations, please refer to the Standards of Care Introduction. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC. CLASSIFICATION Diabetes can be classified into the following general categories: 1. Type1diabetes(duetoautoimmuneb-celldestruction,usuallyleadingtoabsolute insulin deficiency) 2. Type 2 diabetes (due to a progressive loss of b-cell insulin secretion frequently on the background of insulin resistance) 3. Gestational diabetes mellitus (GDM) (diabetes diagnosed in the second or third trimester of pregnancy that was not clearly overt diabetes prior to gestation) 4. Specific types of diabetes due to other causes, e.g., monogenic diabetes syndromes (such as neonatal diabetes and maturity-onset diabetes of the young [MODY]), diseases of the exocrine pancreas (such as cystic fibrosis and pancreatitis), and drug- or chemical-induced diabetes (such as with glucocorticoid use, in the treatment of HIV/AIDS, or after organ transplantation) This section reviews most common forms of diabetes but is not comprehensive. For additional information, see the American Diabetes Association (ADA) position statement “Diagnosis and Classification of Diabetes Mellitus” (1). Type 1 diabetes and type 2 diabetes are heterogeneous diseases in which clinical presentation and disease progression may vary considerably. Classification is im- portant for determining therapy, but some individuals cannot be clearly classified as having type 1 or type 2 diabetes at the time of diagnosis. The traditional paradigms of type 2 diabetes occurring only in adults and type 1 diabetes only in children are no longer accurate, as both diseases occur in both age-groups. Children with type 1 diabetes typically present with the hallmark symptoms of polyuria/polydipsia, and approximately one-third present with diabetic ketoacidosis (DKA) (2). The onset of type 1 diabetes may be more variable in adults, and they may not present with the Suggested citation: American Diabetes Associa- tion. 2. Classification and diagnosis of diabetes: Standards of Medical Care in Diabetesd2019. Diabetes Care 2019;42(Suppl. 1):S13–S28 © 2018 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More infor- mation is available at http://www.diabetesjournals .org/content/license. American Diabetes Association Diabetes Care Volume 42, Supplement 1, January 2019 S13 2.CLASSIFICATIONANDDIAGNOSISOFDIABETES
classic symptoms seen in children. Oc- casionally, patients with type 2 diabetes may present with DKA, particularly ethnic minorities (3). Although difficulties in distinguishing diabetes type may occur in all age-groups at onset, the true diag- nosis becomes more obvious over time. In both type 1 and type 2 diabetes, various genetic and environmental fac- tors can result in the progressive loss of b-cell mass and/or function that mani- fests clinically as hyperglycemia. Once hyperglycemia occurs, patients with all forms of diabetes are at risk for devel- oping the same chronic complications, although rates of progression may differ. The identification of individualized ther- apies for diabetes in the future will re- quirebettercharacterization ofthemany paths to b-cell demise or dysfunction (4). Characterization of the underlying pathophysiology is more developed in type 1 diabetes than in type 2 diabetes. It is now clear from studies of first-degree relatives of patients with type 1 diabetes that the persistent presence of two or more autoantibodies is an almost certain predictor of clinical hyperglycemia and diabetes. The rate of progression is de- pendent on the age at first detection of antibody, number of antibodies, anti- body specificity, and antibody titer. Glu- cose and A1C levels rise well before the clinical onset of diabetes, making diag- nosis feasible well before the onset of DKA. Three distinct stages of type 1 di- abetes can be identified (Table 2.1) and serve as a framework for future research and regulatory decision making (4,5). The paths to b-cell demise and dys- function are less well defined in type 2 diabetes, but deficient b-cell insulin secretion, frequently in the setting of insulin resistance, appears to be the common denominator. Characterization of subtypes of this heterogeneous dis- order have been developed and vali- dated in Scandinavian and Northern European populations but have not been confirmed in other ethnic and racial groups. Type 2 diabetes is primarily as- sociated with insulin secretory defects related to inflammation and metabolic stress among other contributors, includ- ing genetic factors. Future classification schemes for diabetes will likely focus on the pathophysiology of the underly- ing b-cell dysfunction and the stage of disease as indicated by glucose status (normal, impaired, or diabetes) (4). DIAGNOSTIC TESTS FOR DIABETES Diabetes may be diagnosed based on plasma glucose criteria, either the fasting plasma glucose (FPG) value or the 2-h plasma glucose (2-h PG) value during a 75-g oral glucose tolerance test (OGTT), or A1C criteria (6) (Table 2.2). Generally, FPG, 2-h PG during 75-g OGTT, and A1C are equally appropriate for diagnostic testing. It should be noted that the tests do not necessarily detect diabetes in the same individuals. The efficacy of interventions for primary pre- vention of type 2 diabetes (7,8) has primarily been demonstrated among in- dividuals who have impaired glucose tolerance (IGT) with or without elevated fasting glucose, not for individuals with isolated impaired fasting glucose (IFG) or for those with prediabetes defined by A1C criteria. The same tests may be used to screen for and diagnose diabetes and to detect individuals with prediabetes. Diabetes may be identified anywhere along the spectrum of clinical scenarios: in seem- ingly low-risk individuals who happen to haveglucosetesting,inindividualstested based on diabetes risk assessment, and in symptomatic patients. Fasting and 2-Hour Plasma Glucose The FPG and 2-h PG may be used to diagnose diabetes (Table 2.2). The con- cordance between the FPG and 2-h PG tests is imperfect, as is the concordance between A1C and either glucose-based test. Compared with FPG and A1C cut points, the 2-h PG value diagnoses more people with prediabetes and diabetes (9). A1C Recommendations 2.1 To avoid misdiagnosis or missed diagnosis, the A1C test should be performed using a method that is certified by the NGSP and stan- dardized to the Diabetes Control and Complications Trial (DCCT) assay. B 2.2 Marked discordance between mea- sured A1C and plasma glucose levels should raise the possibility of A1C assay interference due to hemoglobin variants (i.e., hemo- globinopathies) and consider- ation of using an assay without interference or plasma blood glu- cose criteria to diagnose diabe- tes. B 2.3 In conditions associated with an altered relationship between A1C and glycemia, such as sickle cell disease, pregnancy (second and third trimesters and the postpar- tum period), glucose-6-phosphate dehydrogenase deficiency, HIV, hemodialysis, recent blood loss or transfusion, or erythropoietin ther- apy, only plasma blood glucose cri- teria should be used to diagnose diabetes. B The A1C test should be performed using a method that is certified by the NGSP (www.ngsp.org) and standardized or traceable to the Diabetes Control and Table 2.1—Staging of type 1 diabetes (4,5) Stage 1 Stage 2 Stage 3 Characteristics c Autoimmunity c Autoimmunity c New-onset hyperglycemia c Normoglycemia c Dysglycemia c Symptomatic c Presymptomatic c Presymptomatic Diagnostic criteria c Multiple autoantibodies c Multiple autoantibodies c Clinical symptoms c No IGT or IFG c Dysglycemia: IFG and/or IGT c Diabetes by standard criteria c FPG 100–125 mg/dL (5.6–6.9 mmol/L) c 2-h PG 140–199 mg/dL (7.8–11.0 mmol/L) c A1C 5.7–6.4% (39–47 mmol/mol) or $10% increase in A1C S14 Classification and Diagnosis of Diabetes Diabetes Care Volume 42, Supplement 1, January 2019
Complications Trial (DCCT) reference assay. Although point-of-care A1C assays may be NGSP certified or U.S. Food and Drug Administration approved for diag- nosis, proficiency testing is not always mandated for performing the test. There- fore, point-of-care assays approved for diagnostic purposes should only be con- sidered in settings licensed to perform moderate-to-high complexity tests. As discussed in Section 6 “Glycemic Targets,” point-of-care A1C assays may be more generally applied for glucose monitoring. The A1C has several advantages com- pared with the FPG and OGTT, including greater convenience (fasting not re- quired), greater preanalytical stability, and less day-to-day perturbations during stress and illness. However, these ad- vantages may be offset by the lower sensitivity of A1C at the designated cut point,greatercost, limitedavailabilityof A1C testing in certain regions of the de- veloping world, and the imperfect corre- lation between A1C and average glucose in certain individuals. The A1C test, with a diagnostic threshold of $6.5% (48 mmol/mol), diagnoses only 30% of the diabetes cases identified collectively using A1C, FPG, or 2-h PG, according to National Health and Nutrition Exam- ination Survey (NHANES) data (10). When using A1C to diagnose diabetes, it is important to recognize that A1C is an indirect measure of average blood glu- cose levels and to take other factors into consideration that may impact hemoglo- bin glycation independently of glycemia including HIV treatment (11,12), age, race/ ethnicity, pregnancy status, genetic back- ground, and anemia/hemoglobinopathies. Age The epidemiological studies that formed the basis for recommending A1C to di- agnose diabetes included only adult pop- ulations (10). However, a recent ADA clinical guidance concluded that A1C, FPG, or 2-h PG can be used to test for prediabetes or type 2 diabetes in chil- dren and adolescents. (see p. S20 SCREEN- ING AND TESTING FOR PREDIABETES AND TYPE 2 DIABETES IN CHILDREN AND ADOLESCENTS for ad- ditional information) (13). Race/Ethnicity/Hemoglobinopathies Hemoglobin variants can interfere with the measurement of A1C, although most assays inuse in theU.S. are unaffected by the most common variants. Marked dis- crepancies between measured A1C and plasma glucose levels should prompt consideration that the A1C assay may not be reliable for that individual. For patients with a hemoglobin variant but normal red blood cell turnover, such as those with the sickle cell trait, an A1C assay without interference from hemo- globin variants should be used. An up- dated list of A1C assays with interferences is available at www.ngsp.org/interf.asp. African Americans heterozygous for the common hemoglobin variant HbS may have, for any given level of mean glycemia, lower A1C by about 0.3% than those without the trait (14). Another ge- neticvariant,X-linkedglucose-6-phosphate dehydrogenase G202A, carried by 11% of African Americans, was associated with a decrease in A1C of about 0.8% in homozygous men and 0.7% in homo- zygous women compared with those without the variant (15). Even in the absence of hemoglobin variants, A1C levels may vary with race/ ethnicity independently of glycemia (16–18). For example, African Americans may have higher A1C levels than non- Hispanic whites with similar fasting and postglucose load glucose levels (19), and A1C levels may be higher for a given mean glucose concentration when measured with continuous glucose monitoring (20). Though conflicting data exists, African Americans may also have higher levels of fructosamine and glycated albumin and lower levels of 1,5-anhydroglucitol, suggest- ing that their glycemic burden (particularly postprandially) may be higher (21,22). The association of A1C with risk for complica- tions appears to be similar in African Amer- icans and non-Hispanic whites (23,24). Other Conditions Altering the Relationship of A1C and Glycemia In conditions associated with increased red blood cell turnover, such as sickle cell disease, pregnancy (second and third trimesters), glucose-6-phosphate dehy- drogenase deficiency (25,26), hemodialy- sis, recent blood loss or transfusion, or erythropoietin therapy, only plasma blood glucosecriteriashouldbeused todiagnose diabetes (27). A1C is less reliable than blood glucose measurement in other con- ditions such as postpartum (28–30), HIV treated with certain drugs (11), and iron- deficient anemia (31). Confirming the Diagnosis Unless there is a clear clinical diagnosis (e.g., patient in a hyperglycemic crisis or with classic symptoms of hyperglyce- mia and a random plasma glucose $200 mg/dL[11.1mmol/L]),diagnosisrequires two abnormal test results from the same sample (32) or in two separate test samples. If using two separate test samples, it is recommended that the second test, which may either be a repeat of the initial test or a different test, be performed without delay. For example, if the A1C is 7.0% (53 mmol/mol) and a repeat result is 6.8% (51 mmol/mol), the diagnosis of diabetes is confirmed. If two different tests (such as A1C and FPG) are both above the diagnostic threshold when analyzed from the same sample or in two different test samples, this also confirms the diagnosis. On the other hand, if a patient has discordant results Table 2.2—Criteria for the diagnosis of diabetes FPG $126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h.* OR 2-h PG $200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water.* OR A1C $6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay.* OR In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose $200 mg/dL (11.1 mmol/L). *In the absence of unequivocal hyperglycemia, diagnosis requires two abnormal test results from the same sample or in two separate test samples. care.diabetesjournals.org Classification and Diagnosis of Diabetes S15
from two different tests, then the test result that is above the diagnostic cut point should be repeated, with consider- ation of the possibility of A1C assay in- terference. The diagnosis is made on the basis of the confirmed test. For example, if a patient meets the diabetes criterion of the A1C (two results $6.5% [48 mmol/mol]) but not FPG (,126 mg/dL [7.0 mmol/L]), that person should never- theless be considered to have diabetes. Since all the tests have preanalytic and analytic variability, it is possible that an abnormal result (i.e., above the diagnostic threshold), when repeated, will produce a value below the diagnostic cut point. This scenario is likely for FPG and2-hPGif the glucose samples remain at room tem- peratureandarenotcentrifugedpromptly. Because of the potential for preanalytic variability, it is critical that samples for plasma glucose be spun and separated immediately after they are drawn. If pa- tientshavetestresultsnearthemarginsof the diagnostic threshold, the health care professional should follow the patient closely and repeat the test in 3–6 months. TYPE 1 DIABETES Recommendations 2.4 Plasma blood glucose rather than A1C should be used to diagnose the acute onset of type 1 diabetes in individuals with symptoms of hyperglycemia. E 2.5 Screening for type 1 diabetes risk with a panel of autoantibodies is currently recommended only in the setting of a research trial or in first-degree family members of a proband with type 1 diabetes. B 2.6 Persistence of two or more auto- antibodies predicts clinical diabe- tes and may serve as an indication for intervention in the setting of a clinical trial. B Diagnosis In a patient with classic symptoms, mea- surement of plasma glucose is sufficient to diagnose diabetes (symptoms of hy- perglycemia or hyperglycemic crisis plus a random plasma glucose $200 mg/dL [11.1 mmol/L]). In these cases, knowing the plasma glucose level is critical be- cause, in addition to confirming that symptoms are due to diabetes, it will in- form management decisions. Some pro- viders may also want to know the A1C to determine how long a patient has had hyperglycemia. The criteria to diagnose diabetes are listed in Table 2.2. Immune-Mediated Diabetes This form, previously called “insulin- dependent diabetes” or “juvenile-onset diabetes,”accountsfor5–10%ofdiabetes and is due to cellular-mediated auto- immune destruction of the pancreatic b-cells. Autoimmune markers include islet cell autoantibodies and autoantibodies to GAD (GAD65), insulin, the tyrosine phos- phatases IA-2 and IA-2b, and ZnT8. Type 1 diabetes is defined by the presence of one or more of these autoimmune markers. The disease has strong HLA associations, with linkage to the DQA and DQB genes. These HLA-DR/DQ alleles can be either predisposing or protective. The rate of b-cell destruction is quite variable, being rapid in some individuals (mainly infants and children) and slow in others (mainly adults). Children and ado- lescents may present with DKA as the first manifestation of the disease. Others have modest fasting hyperglycemia that can rapidly change to severe hyper- glycemia and/or DKA with infection or other stress. Adults may retain sufficient b-cell function to prevent DKA for many years; such individuals eventually be- come dependent on insulin for survival and are at risk for DKA. Atthis latter stage of the disease, there is little or no insulin secretion, as manifested by low or un- detectable levels of plasma C-peptide. Immune-mediated diabetes commonly occurs in childhood and adolescence, but it can occur at any age, even in the 8th and 9th decades of life. Autoimmune destruction of b-cells has multiple genetic predispositions and is also related to environmental factors that are still poorly defined. Al- though patients are not typically obese when they present with type 1 diabetes, obesity should not preclude the diagno- sis. People with type 1 diabetes are also prone to other autoimmune disorders such as Hashimoto thyroiditis, Graves dis- ease, Addison disease, celiac disease, vit- iligo, autoimmune hepatitis, myasthenia gravis, and pernicious anemia (see Section 4 “Comprehensive Medical Evaluation and Assessment of Comorbidities”). Idiopathic Type 1 Diabetes Some forms of type 1 diabetes have no known etiologies. These patients have permanent insulinopenia and are prone to DKA, but have no evidence of b-cell autoimmunity. Although only a minority of patients with type 1 diabetes fall into this category, of those who do, most are of African or Asian ancestry. Individuals with this form of diabetes suffer from episodic DKA and exhibit varying degrees of insulin deficiency between episodes. This form of diabetes is strongly inherited and is not HLA associated. An absolute require- ment for insulin replacement therapy in affected patients may be intermittent. Screening for Type 1 Diabetes Risk The incidence and prevalence of type 1 diabetes is increasing (33). Patients with type 1 diabetes often present with acute symptoms of diabetes and markedly elevated blood glucose levels, and ap- proximately one-third are diagnosed with life-threatening DKA (2). Several studies indicate that measuring islet autoantibodies in relatives of those with type 1 diabetes may identify indi- viduals who are at risk for developing type 1 diabetes (5). Such testing, coupled with education about diabetes symp- toms and close follow-up, may enable earlier identification of type 1 diabetes onset. A study reported the risk of pro- gression to type 1 diabetes from the time of seroconversion to autoantibody pos- itivity in three pediatric cohorts from Finland, Germany, and the U.S. Of the 585 children who developed more than two autoantibodies, nearly 70% devel- oped type 1 diabetes within 10 years and 84% within 15 years (34). These findings are highly significant because while the German group was recruited from off- spring of parents with type 1 diabetes, the Finnish and American groups were recruited from the general population. Remarkably, the findings in all three groups were the same, suggesting that the same sequence of events led to clinical disease in both “sporadic” and familial cases of type 1 diabetes. Indeed, the risk of type 1 diabetes increases as the number of relevant autoantibodies detected increases (35–37). Although there is currently a lack of accepted screening programs, one should consider referring relatives of those with type 1 diabetes for antibody testing for risk assessment in the setting of a clini- cal research study (www.diabetestrialnet .org). Widespread clinical testing of asymp- tomatic low-risk individuals is not currently S16 Classification and Diagnosis of Diabetes Diabetes Care Volume 42, Supplement 1, January 2019
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2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes
2019 ADA standards of medical care in diabetes

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2019 ADA standards of medical care in diabetes

  • 3. American Diabetes Association Standards of Medical Care in Diabetesd2019
  • 5. [T]he simple word Care may suffice to express [the journal’s] philosophical mission. The new journal is designed to promote better patient care by serving the expanded needs of all health professionals committed to the care of patients with diabetes. As such, the American Diabetes Association views Diabetes Care as a reaffirmation of Francis Weld Peabody’s contention that “the secret of the care of the patient is in caring for the patient.” —Norbert Freinkel, Diabetes Care, January-February 1978 EDITOR IN CHIEF Matthew C. Riddle, MD ASSOCIATE EDITORS George Bakris, MD Lawrence Blonde, MD, FACP Andrew J.M. Boulton, MD David D’Alessio, MD Eddie L. Greene, MD Korey K. Hood, PhD Frank B. Hu, MD, MPH, PhD Steven E. Kahn, MB, ChB Sanjay Kaul, MD, FACC, FAHA Derek LeRoith, MD, PhD Robert G. Moses, MD Stephen Rich, PhD Julio Rosenstock, MD Judith Wylie-Rosett, EdD, RD EDITORIAL BOARD Andrew J. Ahmann, MD Vanita R. Aroda, MD Linda A. Barbour, MD, MSPH Roy W. Beck, MD, PhD Gianni Bellomo, MD Geremia Bolli, MD John B. Buse, MD, PhD Sonia Caprio, MD Jessica R. Castle, MD Robert J. Chilton, DO, FACC, FAHA Kenneth Cusi, MD, FACP, FACE J. Hans DeVries, MD, PhD Ele Ferrannini, MD Thomas W. Gardner, MD, MS Jennifer Green, MD Meredith A. Hawkins, MD, MS Petr Heneberg, RNDr, PhD Norbert Hermanns, PhD, MSc Irl B. Hirsch, MD, MACP Reinhard W. Holl, MD, PhD Philip Home, DM, DPhil George S. Jeha, MD Lee M. Kaplan, MD, PhD M. Sue Kirkman, MD Ildiko Lingvay, MD, MPH, MSCS Maureen Monaghan, PhD, CDE Kristen J. Nadeau, MD, MS Gregory A. Nichols, PhD, MBA Kwame Osei, MD Kevin A. Peterson, MD, MPH, FRCS(Ed), FAAFP Ravi Retnakaran, MD, MSc, FRCPC Elizabeth Seaquist, MD Guntram Schernthaner, MD Jan S. Ulbrecht, MB, BS Ram Weiss, MD, PhD Deborah Wexler, MD, MSc Vincent C. Woo, MD, FRCPC Bernard Zinman, CM, MD, FRCPC, FACP AMERICAN DIABETES ASSOCIATION OFFICERS CHAIR OF THE BOARD Karen Talmadge, PhD PRESIDENT, MEDICINE & SCIENCE Jane Reusch, MD PRESIDENT, HEALTH CARE & EDUCATION Felicia Hill-Briggs, PhD, ABPP SECRETARY/TREASURER Michael Ching, CPA CHAIR OF THE BOARD-ELECT David J. Herrick, MBA PRESIDENT-ELECT, MEDICINE & SCIENCE Louis Philipson, MD PRESIDENT-ELECT, HEALTH CARE & EDUCATION Gretchen Youssef, MS, RD, CDE SECRETARY/TREASURER-ELECT Brian Bertha, JD, MBA CHIEF EXECUTIVE OFFICER Tracey D. Brown, MBA, BChE CHIEF SCIENTIFIC, MEDICAL & MISSION OFFICER William T. Cefalu, MD January 2019 Volume 42, Supplement 1 The mission of the American Diabetes Association is to prevent and cure diabetes and to improve the lives of all people affected by diabetes.
  • 6. AMERICAN DIABETES ASSOCIATION PERSONNEL AND CONTACTS ASSOCIATE PUBLISHER, SCHOLARLY JOURNALS Christian S. Kohler EDITORIAL OFFICE DIRECTOR Lyn Reynolds PEER REVIEW MANAGER Shannon Potts ASSOCIATE MANAGER, PEER REVIEW Larissa M. Pouch DIRECTOR, SCHOLARLY JOURNALS Heather Norton Blackburn EDITORIAL CONTENT MANAGER Nancy C. Baldino TECHNICAL EDITORS Theresa Cooper Donna J. Reynolds DIRECTOR, MEMBERSHIP/SUBSCRIPTION SERVICES Donald Crowl SENIOR ADVERTISING MANAGER Julie DeVoss Graff jgraff@diabetes.org (703) 299-5511 ADVERTISING REPRESENTATIVES American Diabetes Association Paul Nalbandian Associate Publisher, Advertising & Sponsorships pnalbandian@diabetes.org (703) 549-1500, ext. 4806 Tina Auletta Senior Account Executive tauletta@diabetes.org (703) 549-1500, ext. 4809 PHARMACEUTICAL/DEVICE DIGITAL ADVERTISING The Walchli Tauber Group Maura Paoletti National Sales Manager maura.paoletti@wt-group.com (443) 512-8899, ext. 110 PRINT ISSN 0149-5992 ONLINE ISSN 1935-5548 PRINTED IN THE USA Diabetes Care is a journal for the health care practitioner that is intended to increase knowledge, stimulate research, and promote better management of people with diabetes. To achieve these goals, the journal publishes original research on human studies in the following categories: Clinical Care/Education/Nutrition/ Psychosocial Research, Epidemiology/Health Services Research, Emerging Technologies and Therapeutics, Pathophysiology/Complications, and Cardiovascular and Metabolic Risk. The journal also publishes ADA statements, consensus reports, clinically relevant review articles, letters to the editor, and health/medical news or points of view. Topics covered are of interest to clinically oriented physicians, researchers, epidemiologists, psychologists, diabetes educators, and other health professionals. More information about the journal can be found online at care.diabetesjournals.org. Copyright © 2018 by the American Diabetes Association, Inc. All rights reserved. Printed in the USA. Requests for permission to reuse content should be sent to Copyright Clearance Center at www.copyright.com or 222 Rosewood Dr., Danvers, MA 01923; phone: (978) 750-8400; fax: (978) 646-8600. Requests for permission to translate should be sent to Permissions Editor, American Diabetes Association, at permissions@diabetes.org. The American Diabetes Association reserves the right to reject any advertisement for any reason, which need not be disclosed to the party submitting the advertisement. Commercial reprint orders should be directed to Sheridan Content Services, (800) 635-7181, ext. 8065. Single issues of Diabetes Care can be ordered by calling toll-free (800) 232-3472, 8:30 A.M. to 5:00 P.M. EST, Monday through Friday. Outside the United States, call (703) 549-1500. Rates: $75 in the United States, $95 in Canada and Mexico, and $125 for all other countries. Diabetes Care is available online at care.diabetesjournals.org. Please call the numbers listed above, e-mail membership@diabetes.org, or visit the online journal for more information about submitting manuscripts, publication charges, ordering reprints, subscribing to the journal, becoming an ADA member, advertising, permission to reuse content, and the journal’s publication policies. Periodicals postage paid at Arlington, VA, and additional mailing offices.
  • 7. January 2019 Volume 42, Supplement 1 Standards of Medical Care in Diabetes—2019 S1 Introduction S3 Professional Practice Committee S4 Summary of Revisions: Standards of Medical Care in Diabetes—2019 S7 1. Improving Care and Promoting Health in Populations Diabetes and Population Health Tailoring Treatment for Social Context S13 2. Classification and Diagnosis of Diabetes Classification Diagnostic Tests for Diabetes A1C Type 1 Diabetes Prediabetes and Type 2 Diabetes Gestational Diabetes Mellitus Cystic Fibrosis–Related Diabetes Posttransplantation Diabetes Mellitus Monogenic Diabetes Syndromes S29 3. Prevention or Delay of Type 2 Diabetes Lifestyle Interventions Pharmacologic Interventions Prevention of Cardiovascular Disease Diabetes Self-management Education and Support S34 4. Comprehensive Medical Evaluation and Assessment of Comorbidities Patient-Centered Collaborative Care Comprehensive Medical Evaluation Assessment of Comorbidities S46 5. Lifestyle Management Diabetes Self-management Education and Support Nutrition Therapy Physical Activity Smoking Cessation: Tobacco and e-Cigarettes Psychosocial Issues S61 6. Glycemic Targets Assessment of Glycemic Control A1C Goals Hypoglycemia Intercurrent Illness S71 7. Diabetes Technology Insulin Delivery Self-monitoring of Blood Glucose Continuous Glucose Monitors Automated Insulin Delivery S81 8. Obesity Management for the Treatment of Type 2 Diabetes Assessment Diet, Physical Activity, and Behavioral Therapy Pharmacotherapy Medical Devices for Weight Loss Metabolic Surgery S90 9. Pharmacologic Approaches to Glycemic Treatment Pharmacologic Therapy for Type 1 Diabetes Surgical Treatment for Type 1 Diabetes Pharmacologic Therapy for Type 2 Diabetes S103 10. Cardiovascular Disease and Risk Management Hypertension/Blood Pressure Control Lipid Management Antiplatelet Agents Cardiovascular Disease S124 11. Microvascular Complications and Foot Care Chronic Kidney Disease Diabetic Retinopathy Neuropathy Foot Care S139 12. Older Adults Neurocognitive Function Hypoglycemia Treatment Goals Lifestyle Management Pharmacologic Therapy Treatment in Skilled Nursing Facilities and Nursing Homes End-of-Life Care S148 13. Children and Adolescents Type 1 Diabetes Type 2 Diabetes Transition From Pediatric to Adult Care S165 14. Management of Diabetes in Pregnancy Diabetes in Pregnancy Preconception Counseling Glycemic Targets in Pregnancy Management of Gestational Diabetes Mellitus Management of Preexisting Type 1 Diabetes and Type 2 Diabetes in Pregnancy Pregnancy and Drug Considerations Postpartum Care S173 15. Diabetes Care in the Hospital Hospital Care Delivery Standards Glycemic Targets in Hospitalized Patients Bedside Blood Glucose Monitoring Antihyperglycemic Agents in Hospitalized Patients Hypoglycemia Medical Nutrition Therapy in the Hospital Self-management in the Hospital Standards for Special Situations Transition From the Acute Care Setting Preventing Admissions and Readmissions S182 16. Diabetes Advocacy Advocacy Statements S184 Disclosures S187 Index This issue is freely accessible online at care.diabetesjournals.org/content/42/Supplement_1. Keep up with the latest information for Diabetes Care and other ADA titles via Facebook (/ADAJournals) and Twitter (@ADA_Journals).
  • 9. Introduction:StandardsofMedical Care in Diabetesd2019 Diabetes Care 2019;42(Suppl. 1):S1–S2 | https://doi.org/10.2337/dc19-SINT01 Diabetes is a complex, chronic illness requiring continuous medical care with multifactorial risk-reduction strategies beyond glycemic control. Ongoing pa- tient self-management education and support are critical to preventing acute complications and reducing the risk of long-term complications. Significant ev- idence exists that supports a range of interventions to improve diabetes out- comes. The American Diabetes Association’s (ADA’s) “Standards of Medical Care in Diabetes,”referredtoastheStandardsof Care, is intended to provide clinicians, patients, researchers, payers, and other interested individuals with the compo- nents of diabetes care, general treat- ment goals, and tools to evaluate the quality of care. The Standards of Care recommendations are not intended to preclude clinical judgment and must be applied in the context of excellent clinical care, with adjustments for in- dividual preferences, comorbidities, and other patient factors. For more detailed information about manage- ment of diabetes, please refer to Med- ical Management of Type 1 Diabetes (1) and Medical Management of Type 2 Diabetes (2). The recommendations include screen- ing, diagnostic, and therapeutic act- ions that are known or believed to favorably affect health outcomes of patients with diabetes. Many of these interventions have also been shown to be cost-effective (3). The ADA strives to improve and update the Standards of Care to ensure that clinicians, health plans, and policy makers can continue to rely on them as the most authoritative and current guidelines for diabetes care. To improve access, the Standards of Care is now available through ADA’s new interactive app, along with tools and calculators that can help guidepatientcare.To download the app, please visit professional.diabetes.org/ SOCapp. Readers who wish to com- ment on the 2019 Standards of Care are invited to do so at professional. diabetes.org/SOC. ADA STANDARDS, STATEMENTS, REPORTS, and REVIEWS TheADAhasbeenactivelyinvolvedinthe development and dissemination of di- abetes care standards, guidelines, and related documents for over 25 years. The ADA’s clinical practice recommendations are viewed as important resources for health care professionals who care for people with diabetes. Standards of Care This document is an official ADA posi- tion, is authored by the ADA, and pro- vides all of the ADA’s current clinical practice recommendations. To update the Standards of Care, the ADA’s Professional Practice Committee (PPC) performs an extensive clinical di- abetes literature search, supple- mented with input from ADA staff and the medical community at large. The PPC updates the Standards of Care annually. However, the Standards of Care is a “living” document, where notable up- dates are incorporated online should the PPC determine that new evidence or regulatory changes (e.g., drug approvals, label changes) merit immediate inclusion. Moreinformationonthe“livingStandards” can be found on DiabetesPro at profes- sional.diabetes.org/content-page/living- standards. The Standards of Care supersedes all previous ADA position statementsdand the recommendations thereindon clinical topics within the purview of the Standards of Care; ADA position statements, while still con- taining valuable analysis, should not be considered the ADA’s current position. The Standards of Care receives annual review and approval by the ADA Board of Directors. ADA Statement An ADA statement is an official ADA point of view or belief that does not contain clinical practice recommenda- tions and may be issued on advocacy, policy, economic, or medical issues re- lated to diabetes. ADA statements undergo a formal review process, including a review by the appropriate national committee, ADA mission staff, and the ADA Board of Directors. Consensus Report A consensus report of a particular topic contains a comprehensive examination and is authored by an expert panel (i.e., “Standards of Medical Care in Diabetes” was originally approved in 1988. Most recent review/revision: December 2018. © 2018 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license. Diabetes Care Volume 42, Supplement 1, January 2019 S1 INTRODUCTION
  • 10. consensus panel) and represents the panel’s collective analysis, evaluation, and opinion. The need for a consensus report arises when clinicians, scientists, regulators, and/or policy makers desire guidance and/or clarity on a medical or scientific issue related to diabetes for which the evidence is contradictory, emerging, or incomplete. Consensus reports may also highlight gaps in evidence and propose areas of future research to address these gaps. A consensus report is not an ADA position and represents expert opinion only but is produced under the auspices of the Association by invited experts. A consensus report may be developed after an ADA Clinical Conference or Re- search Symposium. Scientific Review A scientific review is a balanced review and analysis of the literature on a scien- tific or medical topic related to diabetes. A scientific review is not an ADA po- sition and does not contain clinical prac- tice recommendations but is produced under the auspices of the Association by invited experts. The scientific review may provide a scientific rationale for clinical practice recommendations in the Standards of Care. The category may also include task force and expert committee reports. GRADING OF SCIENTIFIC EVIDENCE Since the ADA first began publishing practice guidelines, there has been con- siderable evolution in the evaluation of scientific evidence and in the develop- ment of evidence-based guidelines. In 2002, the ADA developed a classification system to grade the quality of scientific evidence supporting ADA recommen- dations. A 2015 analysis of the evi- dence cited in the Standards of Care found steady improvement in quality over the previous 10 years, with the 2014 Standards of Care for the first time having the majority of bulleted recommendations supported by A- or B-level evidence (4). A grading system (Table 1) developed by the ADA and modeled after existing methods was used to clarify and codify the evidence that forms the basis for the recommen- dations. ADA recommendations are as- signed ratings of A, B, or C, depending on the quality of evidence. Expert opinion E is a separate category for recommen- dations in which there is no evidence from clinical trials, in which clinical trials may be impractical, or in which there is conflicting evidence. Recommenda- tions with an A rating are based on large well-designed clinical trials or well-done meta-analyses. Generally, these recom- mendations have the best chance of improving outcomes when applied to the population to which they are ap- propriate. Recommendations with lower levels of evidence may be equally im- portant but are not as well supported. Of course, evidence is only one com- ponent of clinical decision making. Clini- cians care for patients, not populations; guidelines must always be interpreted with the individual patient in mind. In- dividualcircumstances,suchascomorbid and coexisting diseases, age, education, disability, and, above all, patients’ values and preferences, must be considered and may lead to different treatment tar- gets and strategies. Furthermore, con- ventional evidence hierarchies, such as the one adapted by the ADA, may miss nuances important in diabetes care. For example, although there is excellent evidence from clinical trials supporting the importance of achieving multiple risk factor control, the optimal way to achieve this result is less clear. It is dif- ficult to assess each component of such a complex intervention. References 1. American Diabetes Association. Medical Management of Type 1 Diabetes. 7th ed. WangCC,ShahAC,Eds.Alexandria,VA,American Diabetes Association, 2017 2. American Diabetes Association. Medical Management of Type 2 Diabetes. 7th ed. Burant CF, Young LA, Eds. Alexandria, VA, American Diabetes Association, 2012 3. Li R, Zhang P, Barker LE, Chowdhury FM, Zhang X. Cost-effectiveness of interventions to prevent and control diabetes mellitus: a sys- tematic review. Diabetes Care 2010;33:1872– 1894 4. Grant RW, Kirkman MS. Trends in the ev- idence level for the American Diabetes As- sociation’s “Standards of Medical Care in Diabetes” from 2005 to 2014. Diabetes Care 2015;38:6–8 Table 1—ADA evidence-grading system for “Standards of Medical Care in Diabetes” Level of evidence Description A Clear evidence from well-conducted, generalizable randomized controlled trials that are adequately powered, including c Evidence from a well-conducted multicenter trial c Evidence from a meta-analysis that incorporated quality ratings in the analysis Compelling nonexperimental evidence, i.e., “all or none” rule developed by the Centre for Evidence-Based Medicine at the University of Oxford Supportive evidence from well-conducted randomized controlled trials that are adequately powered, including c Evidence from a well-conducted trial at one or more institutions c Evidence from a meta-analysis that incorporated quality ratings in the analysis B Supportive evidence from well-conducted cohort studies c Evidence from a well-conducted prospective cohort study or registry c Evidence from a well-conducted meta-analysis of cohort studies Supportive evidence from a well-conducted case-control study C Supportive evidence from poorly controlled or uncontrolled studies c Evidencefromrandomizedclinicaltrialswithoneormoremajororthree or more minor methodological flaws that could invalidate the results c Evidencefromobservationalstudieswithhighpotentialforbias(suchas case series with comparison with historical controls) c Evidence from case series or case reports Conflicting evidence with the weight of evidence supporting the recommendation E Expert consensus or clinical experience S2 Introduction Diabetes Care Volume 42, Supplement 1, January 2019
  • 11. Professional Practice Committee: Standards of Medical Care in Diabetesd2019 Diabetes Care 2019;42(Suppl. 1):S3| https://doi.org/10.2337/dc19-SPPC01 The Professional Practice Committee (PPC) of the American Diabetes Associ- ation (ADA) is responsible for the “Stan- dards of Medical Care in Diabetes,” referred to as the Standards of Care. The PPC is a multidisciplinary expert committee comprised of physicians, diabetes educators, and others who have expertise in a range of areas, including adult and pediatric endocri- nology, epidemiology, public health, lipid research, hypertension, precon- ception planning, and pregnancy care. Appointment to the PPC is based on excellence in clinical practice and re- search. Although the primary role of the PPC is to review and update the Standards of Care, it may also be in- volved in ADA statements, reports, and reviews. The ADA adheres to the National Academy of Medicine Standards for De- veloping Trustworthy Clinical Practice Guidelines. All members of the PPC are required to disclose potential con- flicts of interest with industry and/or other relevant organizations. These dis- closures are discussed at the onset of each Standards of Care revision meeting. Members of the committee, their em- ployers, and their disclosed conflicts of interest are listed in the “Disclosures: Standards of Medical Care in Diabetesd 2019” table (see pp. S184–S186). The ADA funds development of the Stand- ards of Care out of its general revenues and does not use industry support for this purpose. For the current revision, PPC mem- bers systematically searched MEDLINE for human studies related to each section and published since 15 October 2017. Recommendations were revised based on new evidence or, in some cases, to clarify the prior recommendation or match the strength of the wording to the strength of the evidence. A table linking the changes in recommendations to new evidence can be reviewed at professional.diabetes.org/SOC. The Stan- dards of Care was approved by ADA’s Board of Directors, which includes health careprofessionals,scientists,andlaypeople. Feedback from the larger clinical com- munity was valuable for the 2018 revision of the Standards of Care. Readers who wish to comment on the 2019 Standards of Care are invited to do so at professional .diabetes.org/SOC. The PPC would like to thank the fol- lowing individuals who provided their expertise in reviewing and/or consulting withthecommittee:AnnAlbright,PhD,RD; Pamela Allweiss, MD, MPH; Barbara J. Anderson, PhD; George Bakris, MD; Richard Bergenstal, MD; Stuart Brink, MD; Donald R. Coustan, MD; Ellen D. Davis, MS, RN, CDE, FAADE; Jesse Dinh, PharmD; Steven Edelman, MD;BarryH.Ginsberg, MD, PhD; Irl B. Hirsch, MD; Scott Kahan, MD, MPH; David Klonoff, MD; Joyce Lee, MD, MPH; Randie Little, PhD; Alexandra Migdal, MD; Anne Peters, MD; Amy Rothberg, MD; Jennifer Sherr, MD, PhD; Hood Thabit, MB, BCh, MD, PhD; Stuart AlanWeinzimer, MD; and Neil White, MD. Members of the PPC Joshua J. Neumiller, PharmD, CDE, FASCP* (Chair) Christopher P. Cannon, MD Jill Crandall, MD David D’Alessio, MD Ian H. de Boer, MD, MS* Mary de Groot, PhD Judith Fradkin, MD Kathryn Evans Kreider, DNP, APRN, FNP-BC, BC-ADM David Maahs, MD, PhD Nisa Maruthur, MD, MHS Medha N. Munshi, MD* Maria Jose Redondo, MD, PhD, MPH Guillermo E. Umpierrez, MD, CDE, FACE, FACP* Jennifer Wyckoff, MD *Subgroup leaders ADA Nutrition Consensus Report Writing GroupdLiaison Melinda Maryniuk, MEd, RDN, CDE American College of CardiologydDesignated Representatives (Section 10) Sandeep Das, MD, MPH, FACC Mikhail Kosiborod, MD, FACC ADA Staff Erika Gebel Berg, PhD (correspondingauthor:eberg@diabetes.org) Mindy Saraco, MHA Matthew P. Petersen Sacha Uelmen, RDN, CDE Shamera Robinson, MPH, RDN William T. Cefalu, MD © 2018 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license. Diabetes Care Volume 42, Supplement 1, January 2019 S3 PROFESSIONALPRACTICECOMMITTEE
  • 12. Summary of Revisions: Standards of Medical Care in Diabetesd2019 Diabetes Care 2019;42(Suppl. 1):S4–S6 | https://doi.org/10.2337/dc19-srev01 GENERAL CHANGES The field of diabetes care is rapidly changing as new research, technology, and treatments that can improve the health and well-being of people with diabetes continue to emerge. With an- nual updates since 1989, the American Diabetes Association (ADA) has long been a leader in producing guidelines that capture the most current state of the field. To that end, the “Standards of Medical Care in Diabetes” (Standards ofCare)nowincludesadedicatedsection on Diabetes Technology, which contains preexisting material that was previously in other sections that has been consol- idated,aswellasnew recommendations. Another general change is that each rec- ommendation is now associated with a number (i.e., the second recommendation in Section 7 is now recommendation 7.2). Finally, the order of the prevention section was changed (from Section 5 to Section 3) to follow a more logical progression. Although levels of evidence for several recommendations have been updated, these changes are not addressed below as the clinical recommendations have remained the same. Changes in evidence level from, for example, E to C are not noted below. The 2019 Standards of Care contains, in addition to many minor changes that clarify recommendations or reflect new evidence, the following more substantive revisions. SECTION CHANGES Section 1. Improving Care and Promoting Health in Populations Additional information was included on the financial costs of diabetes to individ- uals and society. Because telemedicine is a growing field that may increase access to care forpatientswithdiabetes,discussionwas added on its use to facilitate remote delivery of health-related services and clinical information. Section 2. Classification and Diagnosis of Diabetes Based on new data, the criteria for the diagnosis of diabetes was changed to include two abnormal test results from the same sample (i.e., fasting plasma glucose and A1C from same sample). The section was reorganized to im- prove flow and reduce redundancy. Additional conditions were identified that may affect A1C test accuracy including the postpartum period. Section 3. Prevention or Delay of Type 2 Diabetes This section was moved (previously it was Section 5) and is now located before the Lifestyle Management section to better reflect the progression of type 2 diabetes. The nutrition section was updated to highlight the importance of weight loss for those at high risk for developing type 2 diabetes who have overweight or obesity. Because smoking may increase the risk of type 2 diabetes, a section on tobacco use and cessation was added. Section 4. Comprehensive Medical Evaluation and Assessment of Comorbidities On the basis of a new consensus report on diabetes and language, new text was added to guide health care professionals’ use of language to communicate about diabetes with people with diabetes and professional audiences inan informative, empowering, and educational style. A new figure from the ADA-European Association for the Study of Diabetes (EASD) consensus report about the di- abetes care decision cycle was added to emphasize the need for ongoing assess- ment and shared decision making to achieve the goals of health care and avoid clinical inertia. A new recommendation was added to explicitly call out the importance of the diabetes care team and to list the pro- fessionals that make up the team. The table listing the components of a comprehensive medical evaluation was revised, and the section on assessment and planning was used to create a new table (Table 4.2). A new table was added listing factors that increase risk of treatment-associated hypoglycemia (Table 4.3). A recommendation was added to in- clude the 10-year atherosclerotic cardio- vascular disease (ASCVD) risk as part of overall risk assessment. The fatty liver disease section was revised to include updated text and a new recommendation regarding when to test for liver disease. Section 5. Lifestyle Management Evidence continues to suggest that there is not an ideal percentage of calories from carbohydrate, protein, and fat for all people with diabetes. Therefore, more discussion was added about the im- portance of macronutrient distribution based on an individualized assessment of currenteatingpatterns,preferences,and metabolic goals. Additional considera- tions were added to the eating © 2018 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license. S4 Diabetes Care Volume 42, Supplement 1, January 2019 SUMMARYOFREVISIONS
  • 13. patterns, macronutrient distribution, and meal planning sections to better iden- tify candidates for meal plans, specifically for low-carbohydrate eating patterns and people who are pregnant or lactat- ing, who have or are at risk for disor- dered eating, who have renal disease, and who are taking sodium–glucose co- transporter 2 inhibitors. There is not a one-size-fits-all eating pattern for in- dividuals with diabetes, and meal plan- ning should be individualized. A recommendation was modified to encourage people with diabetes to de- crease consumption of both sugar sweetened and nonnutritive-sweetened beverages and use other alternatives, with an emphasis on water intake. The sodium consumption recommen- dation was modified to eliminate the further restriction that was potentially indicated for those with both diabetes and hypertension. Additional discussion was added to the physical activity section to include the ben- efit of a variety of leisure-time physical ac- tivities and flexibility and balance exercises. The discussion about e-cigarettes was expanded to include more on public perception and how their use to aide smoking cessation was not more effec- tive than “usual care.” Section 6. Glycemic Targets This section now begins with a discussion of A1C tests to highlight the centrality of A1C testing in glycemic management. The self-monitoring of blood glucose and continuous glucose monitoring text and recommendations were moved to the new Diabetes Technology section. To emphasize that the risks and ben- efits of glycemic targets can change as diabetes progresses and patients age, a recommendation was added to reeval- uate glycemic targets over time. The section was modified to align with the living Standards updates made in April 2018 regarding the consensus definition of hypoglycemia. Section 7. Diabetes Technology This new section includes new recommen- dations, the self-monitoring of blood glu- cose section formerly included in Section 6 “Glycemic Targets,” and a discussion of insulindeliverydevices(syringes,pens,and insulin pumps), blood glucose meters, con- tinuous glucose monitors (real-time and intermittently scanned [“flash”]), and au- tomated insulin delivery devices. The recommendation to use self- monitoring of blood glucose in people who are not using insulin was changed to acknowledge that routine glucose monitoring is of limited additional clin- ical benefit in this population. Section 8. Obesity Management for the Treatment of Type 2 Diabetes A recommendation was modified to acknowledge the benefits of tracking weight, activity, etc., in the context of achieving and maintaining a healthy weight. A brief section was added on medical devices for weight loss, which are not currently recommended due to limited data in people with diabetes. The recommendations for metabolic surgery were modified to align with re- cent guidelines, citing the importance of considering comorbidities beyond dia- betes when contemplating the ap- propriateness of metabolic surgery for a given patient. Section 9. Pharmacologic Approaches to Glycemic Treatment The section on the pharmacologic treat- ment of type 2 diabetes was signifi- cantly changed to align, as per the living Standards update in October 2018, with the ADA-EASD consensus report on this topic, summarized in the new Figs. 9.1 and 9.2. This includes consideration of key patient factors: a) important comorbidities such as ASCVD, chronic kidney disease, and heart failure, b) hypoglycemia risk, c) effects on body weight, d) side effects, e) costs, and f) patient preferences. To align with the ADA-EASD con- sensus report, the approach to inject- able medication therapy was revised (Fig. 9.2). A recommendation that, for most patients who need the greater efficacy of an injectable medication, a glucagon-like peptide 1 receptor ago- nist should be the first choice, ahead of insulin. A new section was added on insulin injection technique, emphasizing the im- portance of technique for appropriate insulin dosing and the avoidance of com- plications (lipodystrophy, etc.). The section on noninsulin pharmaco- logic treatments for type 1 diabetes was abbreviated, as these are not generally recommended. Section 10. Cardiovascular Disease and Risk Management For the first time, this section is endorsed by the American College of Cardiology. Additional text was added to acknowl- edge heart failure as an important type of cardiovascular disease in people with diabetes for consideration when deter- mining optimal diabetes care. The blood pressure recommenda- tions were modified to emphasize the importance of individualization of targets based on cardiovascular risk. A discussion of the appropriate use of the ASCVD risk calculator was included, and recommendations were modified to include assessment of 10-year ASCVD risk as part of overall risk assessment and in determining optimal treatment approaches. The recommendation and text regard- ing the use of aspirin in primary pre- vention was updated with new data. For alignment with the ADA-EASD consensusreport, two recommendations were added for the use of medications thathaveprovencardiovascularbenefitin people with ASCVD, with and without heart failure. Section 11. Microvascular Complications and Foot Care To align with the ADA-EASD consensus report, a recommendation was added for people with type 2 diabetes and chronic kidney disease to consider agents with proven benefit with regard to renal out- comes. The recommendation on the use of telemedicine in retinal screening was modified to acknowledge the utility of this approach, so long as appropriate referrals are made for a comprehensive eye examination. Gabapentin was added to the list of agents to be considered for the treat- ment of neuropathic pain in people with diabetes based on data on efficacy and the potential for cost savings. The gastroparesis section includes a discussion of a few additional treatment modalities. The recommendation for patients with diabetes to have their feet inspected at every visit was modified to only include those at high risk for ulceration. Annual care.diabetesjournals.org Summary of Revisions S5
  • 14. examinations remain recommended for everyone. Section 12. Older Adults A new section and recommendation on lifestyle management was added to address the unique nutritional and physical activity needs and considerations for older adults. Within the pharmacologic therapy discussion, deintensification of insulin re- gimes was introduced to help simplify insulin regimen to match individual’s self-management abilities. A new figure was added (Fig. 12.1) that provides a path for simplification. A new table was also added (Table 12.2) to help guide providers considering medication regimen simplifi- cation and deintensification/deprescrib- ing in older adults with diabetes. Section 13. Children and Adolescents Introductory language was added to the beginning of this section reminding the reader that the epidemiology, patho- physiology, developmental consider- ations, and response to therapy in pediatric-onset diabetes are different from adult diabetes, and that there are also differences in recommended care for children and adolescents with type 1 as opposed to type 2 diabetes. A recommendation was added to em- phasize the need for disordered eating screening in youth with type 1 diabetes beginning at 10–12 years of age. Based on new evidence, a recom- mendation was added discouraging e-cigarette use in youth. The discussion of type 2 diabetes in children and adolescents was significantly expanded, with new recommendations in a number of areas, including screen- ing and diagnosis, lifestyle management, pharmacologic management, and transi- tion of care to adult providers. New sections and/or recommendations for type 2 diabetes in children and adoles- cents were added for glycemic targets, metabolic surgery, nephropathy, neurop- athy, retinopathy, nonalcoholic fatty liver disease, obstructive sleep apnea, poly- cystic ovary syndrome, cardiovascular disease, dyslipidemia, cardiac function testing, and psychosocial factors. Figure 13.1 was added to provide guidance on the management of diabetes in overweight youth. Section 14. Management of Diabetes in Pregnancy Women with preexisting diabetes are now recommended to have their care managed in a multidisciplinary clinic to improve diabetes and pregnancy out- comes. Greater emphasis has been placed on the use of insulin as the preferred med- ication for treating hyperglycemia in gestational diabetes mellitus as it does not cross the placenta to a measurable extent and how metformin and gly- buride should not be used as first- line agents as both cross the placenta to the fetus. Section 15. Diabetes Care in the Hospital Because of their ability to improve hos- pital readmission rates and cost of care, a new recommendation was added call- ing for providers to consider consulting with a specialized diabetes or glucose management team where possible when caring for hospitalized patients with diabetes. Section 16. Diabetes Advocacy The “Insulin Access and Affordability Working Group: Conclusions and Recommendations” ADA statement was added to this section. Published in 2018, this statement compiled public informa- tion and convened a series of meetings with stakeholders throughout the in- sulin supply chain to learn how each entity affects the cost of insulin for the consumer, an important topic for the ADA and people living with diabetes. S6 Summary of Revisions Diabetes Care Volume 42, Supplement 1, January 2019
  • 15. 1. Improving Care and Promoting Health in Populations: Standards of Medical Care in Diabetesd2019 Diabetes Care 2019;42(Suppl. 1):S7–S12 | https://doi.org/10.2337/dc19-S001 The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes” includes ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations, please refer to the Standards of Care Introduction. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC. DIABETES AND POPULATION HEALTH Recommendations 1.1 Ensure treatment decisions are timely, rely on evidence-based guidelines, and are made collaboratively with patients based on individual preferences, prog- noses, and comorbidities. B 1.2 Align approaches to diabetes management with the Chronic Care Model, emphasizing productive interactions between a prepared proactive care team and an informed activated patient. A 1.3 Care systems should facilitate team-based care, patient registries, decision support tools, and community involvement to meet patient needs. B 1.4 Efforts to assess the quality of diabetes care and create quality improvement strategies should incorporate reliable data metrics, to promote improved pro- cesses of care and health outcomes, with simultaneous emphasis on costs. E Population health is defined as “the health outcomes of a group of individuals, including the distribution of health outcomes within the group”; these outcomes can bemeasuredintermsofhealthoutcomes(mortality,morbidity,health,andfunctional status), disease burden (incidence and prevalence), and behavioral and metabolic factors(exercise,diet,A1C,etc.)(1).Clinicalpracticerecommendationsforhealthcare providers are tools that can ultimately improve health across populations; however, for optimal outcomes, diabetes care must also be individualized for each patient. Thus, efforts to improve population health will require a combination of system-level and patient-level approaches. With such an integrated approach in mind, the American Diabetes Association (ADA) highlights the importance of patient-centered care, defined as care that is respectful of and responsive to individual patient preferences, needs, and values and that ensures that patient values guide all clinical decisions (2). Clinical practice recommendations, whether based on evidence or expert opinion, are Suggested citation: American Diabetes Associa- tion. 1. Improving care and promoting health in populations: Standards of Medical Care in Diabetesd2019. Diabetes Care 2019;42(Suppl. 1): S7–S12 © 2018 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More infor- mation is available at http://www.diabetesjournals .org/content/license. American Diabetes Association Diabetes Care Volume 42, Supplement 1, January 2019 S7 1.IMPROVINGCAREANDPROMOTINGHEALTH
  • 16. intended to guide an overall approach to care. The science and art of medicine come together when the clinician is faced with making treatment recommenda- tions for a patient who may not meet the eligibility criteria used in the studies on which guidelines are based. Recog- nizing that one size does not fit all, the standards presented here provide guid- ance for when and how to adapt rec- ommendations for an individual. Care Delivery Systems The proportion of patients with diabetes who achieve recommended A1C, blood pressure, and LDL cholesterol levels has increased in recent years (3). The mean A1C nationally among people with diabe- tes declined from 7.6% (60 mmol/mol) in 1999–2002 to 7.2% (55 mmol/mol) in 2007–2010 based on the National Health and Nutrition Examination Survey (NHANES), with younger adults less likely to meet treatment targets than older adults (3). This has been accompanied by improvements in cardiovascular out- comes and has led to substantial re- ductions in end-stage microvascular complications. Nevertheless, 33–49% of patients still did not meet general targets for glyce- mic, blood pressure, or cholesterol con- trol, and only 14% met targets for all three measures while also avoiding smok- ing(3).Evidencesuggests that progress in cardiovascular risk factor control (partic- ularly tobacco use) may be slowing (3,4). Certain segments of the population, such asyoungadultsandpatientswithcomplex comorbidities, financial or other social hardships, and/or limited English pro- ficiency, face particular challenges to goal-based care (5–7). Even after adjust- ing for these patient factors, the persis- tent variability in the quality of diabetes care across providers and practice set- tings indicates that substantial system- level improvements are still needed. Diabetes poses a significant financial burden to individuals and society. It is estimated that the annual cost of di- agnosed diabetes in 2017 was $327 billion, including $237 billion in direct medical costs and $90 billion in reduced productivity. After adjusting for inflation, economic costs of diabetes increased by 26% from 2012 to 2017 (8). This is attributed to the increased prevalence of diabetes and the increased cost per person with diabetes. Ongoing population health strategies are needed in order to reduce costs and provide optimized care. Chronic Care Model Numerous interventions to improve ad- herence to the recommended standards have been implemented. However, a major barrier to optimal care is a delivery system that is often fragmented, lacks clinical information capabilities, dupli- cates services, and is poorly designed for the coordinated delivery of chronic care. The Chronic Care Model (CCM) takes these factors into consideration and is an effective framework for im- proving the quality of diabetes care (9). Six Core Elements. The CCM includes six core elements to optimize the care of patients with chronic disease: 1. Delivery system design (moving from a reactive to a proactive care delivery system where planned visits are coordinated through a team-based approach) 2. Self-management support 3. Decision support (basing care on evidence-based, effective care guidelines) 4. Clinical information systems (using registries that can provide patient- specific and population-based sup- port to the care team) 5. Community resources and policies (identifying or developing resources to support healthy lifestyles) 6. Health systems (to create a quality- oriented culture) Redefining the roles of the health care delivery team and empowering patient self-management are fundamental to the successful implementation of the CCM (10). Collaborative, multidisciplinary teams are best suited to provide care for people with chronic conditions such as diabetes and to facilitate patients’ self-management (11–13). Strategies for System-Level Improvement Optimal diabetes management requires an organized, systematic approach and the involvement of a coordinated team of dedicated health care professionals work- ing in an environment where patient- centered high-quality care is a priority (7,14,15). While many diabetes pro- cesses of care have improved nationally in the past decade, the overall quality of care for patients with diabetes remains suboptimal (3). Efforts to increase the quality of diabetes care include provid- ing care that is concordant with evidence-based guidelines (16); expand- ing the role of teams to implement more intensive disease management strate- gies (7,17,18); tracking medication- taking behavior at a systems level (19); redesigning the organization of the care process (20); implementing electronic health record tools (21,22); empowering and educating patients (23,24); removing financial barriers and reducing patient out-of-pocket costs for diabetes educa- tion, eye exams,diabetes technology,and necessary medications (7); assessing and addressing psychosocial issues (25,26); and identifying, developing, and engaging community resources and public policies that support healthy lifestyles (27). The National Diabetes Education Program maintains an online resource (www .betterdiabetescare.nih.gov)tohelphealth care professionals design and implement moreeffectivehealthcaredeliverysystems for those with diabetes. The care team, which centers around the patient, should avoid therapeutic inertia and prioritize timely and appro- priate intensification of lifestyle and/or pharmacologic therapy for patients who have not achieved the recommended metabolic targets (28–30). Strategies shown to improve care team behavior and thereby catalyze reductions in A1C, blood pressure, and/or LDL cholesterol include engaging in explicit and collab- orative goal setting with patients (31,32); identifying and addressing language, numeracy, or cultural barriers to care (33–35); integrating evidence-based guide- lines and clinical information tools into the process of care (16,36,37); soliciting performance feedback, setting reminders, and providing structured care (e.g., guidelines, formal case manage- ment, and patient education resources) (7); and incorporating care management teams including nurses, dietitians, phar- macists, and other providers (17,38). Initiatives such as the Patient-Centered Medical Home show promise for im- proving health outcomes by fostering comprehensive primary care and offer- ing new opportunities for team-based chronic disease management (39). Telemedicine is a growing field that may increase access to care for patients with diabetes. Telemedicine is defined as the use of telecommunications to S8 Improving Care and Promoting Health Diabetes Care Volume 42, Supplement 1, January 2019
  • 17. facilitate remote delivery of health-re- lated services and clinical information (40). A growing body of evidence sug- gests that various telemedicine modali- ties may be effective at reducing A1C in patients with type 2 diabetes compared with usual care or in addition to usual care (41). For rural populations or those with limited physical access to health care, telemedicine has a growing body of evidenceforits effectiveness, particularly with regard to glycemic control as mea- sured by A1C (42–44). Interactive strat- egies that facilitate communication between providersandpatients,including the use of web-based portals or text messaging and those that incorporate medication adjustment, appear more effective. There is limited data avail- able on the cost-effectiveness of these strategies. Successful diabetes care also requires a systematic approach to supporting patients’ behavior change efforts. High-quality diabetes self-management education and support (DSMES) has been shown to improve patient self- management, satisfaction, and glucose outcomes. National DSMES standards call for an integrated approach that in- cludes clinical content and skills, behav- ioral strategies (goal setting, problem solving), and engagement with psycho- social concerns (26). For more informa- tion on DSMES, see Section 5 “Lifestyle Management.” In devising approaches to support disease self-management, it is notable that in 23% of cases, uncontrolled A1C, blood pressure, or lipids were associated with poor medication-taking behaviors (“medication adherence”) (19). At a sys- tem level, “adequate” medication taking is defined as 80% (calculated as the number of pills taken by the patient in a given time period divided by the number of pills prescribed by the physi- cian in that same time period) (19). If medication taking is 80% or above and treatment goals are not met, then treatment intensification should be considered (e.g., uptitration). Barriers to medication taking may include patient factors (financial limitations, remembering to obtain or take medica- tions, fear, depression, or health beliefs), medication factors (complexity, multiple daily dosing, cost, or side effects), and system factors (inadequate follow- up or support). Success in overcoming barriers to medication taking may be achieved if the patient and provider agree on a targeted approach for a spe- cific barrier (12). The Affordable Care Act has resulted in increased access to care for many individuals with diabetes with an empha- sis on the protection of people with preexisting conditions, health promotion, anddiseaseprevention(45).Infact,health insurance coverage increased from 84.7% in 2009 to 90.1% in 2016 for adults with diabetes aged 18–64 years. Coverage for those $65 years remained near universal (46). Patients who have eitherprivate orpublicinsurance coverage are more likely to meet quality indicators for diabetes care (47). As mandated by the Affordable Care Act, the Agency for Healthcare Research and Quality developed a National Quality Strategy based on the triple aims that include improving the health of a population, overall quality and patient experience of care, and per capita cost (48,49). As health care systems and practices adapt to the changing landscape of health care, it will be important to integrate traditional disease-specific metrics with measures of patient experience, as well as cost, in assessing the quality of diabe- tes care (50,51). Information and guid- ance specific to quality improvement and practice transformation for diabetes care is available from the National Diabetes Education Program practice transforma- tion website and the National Institute of Diabetes and Digestive and Kidney Dis- eases report on diabetes care and quality (52,53). Using patient registries and elec- tronic health records, health systems can evaluate the quality of diabetes care being delivered and perform interven- tion cycles as part of quality improve- ment strategies (54). Critical to these efforts is provider adherence to clinical practice recommendations and accu- rate, reliable data metrics that include sociodemographic variables to examine health equity within and across popula- tions (55). In addition to quality improvement efforts, other strategies that simulta- neously improve the quality of care and potentially reduce costs are gaining momentum and include reimbursement structures that, in contrast to visit-based billing, reward the provision of appro- priate and high-quality care to achieve metabolic goals (56) and incentives that accommodate personalized care goals (7,57). TAILORING TREATMENT FOR SOCIAL CONTEXT Recommendations 1.5 Providers should assess social context, including potential food insecurity, housing stabil- ity, and financial barriers, and apply that information to treat- ment decisions. A 1.6 Refer patients to local commu- nity resources when available. B 1.7 Provide patients with self- management support from lay health coaches, navigators, or community health workers when available. A Health inequities related to diabetes and its complications are well docu- mented and are heavily influenced by social determinants of health (58–62). Socialdeterminants ofhealtharedefined as the economic, environmental, politi- cal, and social conditions in which people live and are responsible for a major part of health inequality worldwide (63). The ADA recognizes the association between social and environmental factors and the prevention and treatment of diabetes and has issued a call for research that seeks to better understand how these social determinants influence behaviors and how the relationships between these variables might be modified for the pre- vention and management of diabetes (64). While a comprehensive strategy to reduce diabetes-related health inequi- ties in populations has not been for- mally studied, general recommendations from other chronic disease models can be drawn upon to inform systems-level strategies in diabetes. For example, the National Academy of Medicine has published a framework for educating health care professionals on the impor- tance of social determinants of health (65). Furthermore, there are resources available for the inclusion of standard- ized sociodemographic variables in elec- tronic medical records to facilitate the measurement of health inequities as well as the impact of interventions de- signed toreducethose inequities(66–68). Social determinants of health are not always recognized and often go undis- cussed in the clinical encounter (61). A care.diabetesjournals.org Improving Care and Promoting Health S9
  • 18. study by Piette et al. (69) found that among patients with chronic illnesses, two-thirds of those who reported not taking medications as prescribed due to cost never shared this with their physi- cian. In a more recent study using data from the National Health Interview Survey (NHIS), Patel et al. (61) found that half of adults with diabetes reported financial stress and one-fifth reported food insecurity (FI). One population in which such issues must be considered is olderadults,where socialdifficultiesmay impair their quality of life and increase their risk of functional dependency (70) (see Section 12 “Older Adults” for a de- tailed discussion of social considerations in older adults). Creating systems-level mechanisms to screen for social deter- minants of health may help overcome structural barriers and communication gaps between patients and providers (61). In addition, brief, validated screen- ing tools for some social determinants of health exist and could facilitate discus- sion around factors that significantly impact treatment during the clinical en- counter. Below is a discussion of assess- ment and treatment considerations in the context of FI, homelessness, and limited English proficiency/low literacy. Food Insecurity FI is the unreliable availability of nutri- tious food and the inability to consis- tently obtain food without resorting to socially unacceptable practices. Over 14% (or one of every seven people) of the U.S. population is food insecure. The rate is higher in some racial/ethnic minority groups, including African American and Latino populations, in low-income households, and in homes headed by a single mother. The risk for type 2 diabetes is increased twofold in those with FI (64) and has been associ- ated with low adherence to taking medi- cations appropriately and recommended self-care behaviors, depression, diabe- tes distress, and worse glycemic control when compared with individuals who are food secure (71,72). Risk for FI can be assessed with a validated two-item screening tool (73) that includes the statements: 1) “Within the past 12 months we worried whether our food would run out before we got money to buy more” and 2) “Within the past 12 months the food we bought just didn’t last and we didn’t have money to get more.” An affirmative response to either statement had a sensitivity of 97% and specificity of 83%. Treatment Considerations In those with diabetes and FI, the priority is mitigating the increased risk for un- controlled hyperglycemia and severe hy- poglycemia. Reasons for the increased risk of hyperglycemia include the steady consumption of inexpensive carbohy- drate-rich processed foods, binge eat- ing, financial constraints to the filling of diabetes medication prescriptions, and anxiety/depression leading to poor diabetes self-care behaviors. Hypoglyce- mia can occur as a result of inadequate or erratic carbohydrate consumption following the administration of sul- fonylureas or insulin. See Table 9.1 for drug-specific and patient factors, includ- ing cost and risk of hypoglycemia, for treatment options for adults with FI and type 2 diabetes. Providers should con- sider these factors when making treat- ment decisions in people with FI and seek local resources that might help patients with diabetes and their family members to more regularly obtain nutritious food (74). Homelessness Homelessness often accompanies many additional barriers to diabetes self- management, including FI, literacy and numeracy deficiencies, lack of insurance, cognitive dysfunction, and mental health issues. Additionally, patients with diabe- tes who are homeless need secure places to keep their diabetes supplies and re- frigerator access to properly store their insulin and take it on a regular schedule. Risk for homelessness can be ascertained using a brief risk assessment tool de- veloped and validated for use among veterans (75). Given the potential chal- lenges, providers who care for homeless individuals should be familiar with re- sources or have access to social workers that can facilitate temporary housing for their patients as a way to improve diabetes care. Language Barriers Providers who care for non-English speakers should develop or offer educa- tional programs and materials in multiple languages with the specific goals of pre- venting diabetes and building diabetes awareness in people who cannot easily read or write in English. The National Standards for Culturally and Linguisti- cally Appropriate Services in Health and Health Care provide guidance on how health care providers can reduce language barriers by improving their cultural competency, addressing health literacy, and ensuring communication with language assistance (76). The site offers a number of resources and materi- als that can be used to improve the quality of care delivery to non-English–speaking patients. Community Support Identification or development of com- munity resources to support healthy lifestyles is a core element of the CCM (9). Health care community linkages are receiving increasing attention from the American Medical Association, the Agency for Healthcare Research and Quality, and others as a means of pro- moting translation of clinical recommen- dations for lifestyle modification in real- world settings (77). Community health workers (CHWs) (78), peer supporters (79–81), and lay leaders (82) may assist in the delivery of DSMES services (66), particularly in underserved communi- ties. A CHW is defined by the American Public Health Association as a “frontline public health worker who is a trusted member of and/or has an unusually close understanding of the community served” (83). CHWs can be part of a cost-effective, evidence-based strategy to improve the management of diabetes and car- diovascular risk factors in underserved communities and health care systems (84). References 1. Kindig D, Stoddart G. What is population health? Am J Public Health 2003;93:380–383 2. Institute of Medicine Committee on Quality of Health Care in America. Crossing the quality chasm: a new health system for the 21st century [Internet], 2001. Washington, DC, The National Academies Press. Available from http://www .nap.edu/catalog/10027. Accessed 22 October 2018 3. Ali MK, Bullard KM, Saaddine JB, Cowie CC, Imperatore G, Gregg EW. Achievement of goals in U.S. diabetes care, 1999-2010. N Engl J Med 2013;368:1613–1624 4. Wang J, Geiss LS, Cheng YJ, et al. Long-term and recent progress in blood pressure levels among U.S. adults with diagnosed diabetes, 1988-2008. Diabetes Care 2011;34:1579–1581 5. Kerr EA, Heisler M, Krein SL, et al. Beyond comorbidity counts: how do comorbidity type and severity influence diabetes patients’ treat- ment priorities and self-management? J Gen Intern Med 2007;22:1635–1640 S10 Improving Care and Promoting Health Diabetes Care Volume 42, Supplement 1, January 2019
  • 19. 6. Fernandez A, Schillinger D, Warton EM, et al. Language barriers, physician-patient language concordance, and glycemic control among in- sured Latinos with diabetes: the Diabetes Study of Northern California (DISTANCE). J Gen Intern Med 2011;26:170–176 7. TRIAD Study Group. Health systems, patients factors, and quality of care for diabetes: a syn- thesis of findings from the TRIAD study. Diabetes Care 2010;33:940–947 8. American Diabetes Association. Economic costs of diabetes in the U.S. in 2017. Diabetes Care 2018;41:917–928 9. Stellefson M, Dipnarine K, Stopka C. The Chronic Care Model and diabetes management in US primary care settings: a systematic review. Prev Chronic Dis 2013;10:E26 10. Coleman K, Austin BT, Brach C, Wagner EH. Evidence on the Chronic Care Model in the new millennium. Health Aff (Millwood) 2009;28:75–85 11. Piatt GA, Anderson RM, Brooks MM, et al. 3-year follow-up of clinical and behavioral im- provements following a multifaceted diabetes care intervention: results of a randomized con- trolled trial. Diabetes Educ 2010;36:301–309 12. Katon WJ, Lin EHB, Von Korff M, et al. Collaborative care for patients with depression and chronic illnesses. N Engl J Med 2010;363: 2611–2620 13. ParchmanML,ZeberJE,RomeroRR,PughJA. Risk of coronary artery disease in type 2 diabetes and the delivery of care consistent with the chronic care model in primary care settings: a STARNet study. Med Care 2007;45:1129–1134 14. Tricco AC, Ivers NM, Grimshaw JM, et al. Effectiveness of quality improvement strategies on the management of diabetes: a systematic review and meta-analysis. Lancet 2012;379:2252–2261 15. Schmittdiel JA, Gopalan A, Lin MW, Banerjee S, Chau CV, Adams AS. Population health man- agement for diabetes: health care system-level approaches for improving quality and addressing disparities. Curr Diab Rep 2017;17:31 16. O’Connor PJ, Bodkin NL, Fradkin J, et al. Diabetes performance measures: current status and future directions. Diabetes Care 2011;34: 1651–1659 17. Jaffe MG, Lee GA, Young JD, Sidney S, Go AS. Improved blood pressure control associated with a large-scale hypertension program. JAMA 2013;310:699–705 18. Peikes D, Chen A, Schore J, Brown R. Effects ofcarecoordinationonhospitalization,qualityof care, and health care expenditures among Medi- care beneficiaries: 15 randomized trials. JAMA 2009;301:603–618 19. Raebel MA, Schmittdiel J, Karter AJ, Konieczny JL, Steiner JF. Standardizing terminol- ogy and definitions of medication adherence and persistence in research employing electronic databases. Med Care 2013;51(Suppl. 3):S11–S21 20. Feifer C, Nemeth L,Nietert PJ, et al. Different paths to high-quality care: three archetypes of top-performing practice sites. Ann Fam Med 2007;5:233–241 21. Reed M, Huang J, Graetz I, et al. Outpatient electronic health records and the clinical care and outcomes of patients with diabetes mellitus. Ann Intern Med 2012;157:482–489 22. Cebul RD, Love TE, Jain AK, Hebert CJ. Electronic health records and quality of diabetes care. N Engl J Med 2011;365:825–833 23. Battersby M, Von Korff M, Schaefer J, et al. Twelve evidence-based principles for imple- menting self-management support in primary care. Jt Comm J Qual Patient Saf 2010;36:561– 570 24. Grant RW, Wald JS, Schnipper JL, et al. Practice-linked online personal health records for type 2 diabetes mellitus: a randomized con- trolled trial. Arch Intern Med 2008;168:1776– 1782 25. Young-Hyman D, de Groot M, Hill-Briggs F, Gonzalez JS, Hood K, Peyrot M. Psychosocial care for people with diabetes: a position statement of the American Diabetes Association. Diabetes Care 2016;39:2126–2140 26. Beck J, Greenwood DA, Blanton L, et al.; 2017 Standards Revision Task Force. 2017 Na- tional standards for diabetes self-management education and support. Diabetes Care 2017; 40:1409–1419 27. Pullen-Smith B, Carter-Edwards L, Leathers KH. Community health ambassadors: a model for engaging community leaders to promote better health in North Carolina. J Public Health Manag Pract 2008;14(Suppl.):S73–S81 28. Davidson MB. How our current medical care system fails people with diabetes: lack of timely, appropriate clinical decisions. Diabetes Care 2009;32:370–372 29. Selby JV, Uratsu CS, Fireman B, et al. Treat- ment intensification and risk factor control: to- ward more clinically relevant quality measures. Med Care 2009;47:395–402 30. Raebel MA, Ellis JL, Schroeder EB, et al. Intensification of antihyperglycemic ther- apy among patients with incident diabetes: a Surveillance Prevention and Management of Diabetes Mellitus (SUPREME-DM) study. Pharmacoepidemiol Drug Saf 2014;23:699– 710 31. Grant RW, Pabon-Nau L, Ross KM, Youatt EJ, Pandiscio JC, Park ER. Diabetes oral medication initiation and intensification: patient views com- pared with current treatment guidelines. Diabe- tes Educ 2011;37:78–84 32. Tamhane S, Rodriguez-Gutierrez R, Hargraves I, Montori VM. Shared decision-making in diabe- tes care. Curr Diab Rep 2015;15:112 33. Schillinger D, Piette J, Grumbach K, et al. Closing the loop: physician communication with diabetic patients who have low health literacy. Arch Intern Med 2003;163:83–90 34. Rosal MC, Ockene IS, Restrepo A, et al. Randomized trial of a literacy-sensitive, culturally tailored diabetes self-management intervention for low-income Latinos: Lati- nos en control. Diabetes Care 2011;34:838– 844 35. Osborn CY, Cavanaugh K, Wallston KA, et al. Health literacy explains racial disparities in di- abetes medication adherence. J Health Commun 2011;16(Suppl. 3):268–278 36. Garg AX, Adhikari NKJ, McDonald H, et al. Effects of computerized clinical decision support systemsonpractitionerperformanceandpatient outcomes: a systematic review. JAMA 2005;293: 1223–1238 37. Smith SA, Shah ND, Bryant SC, et al.; Evidens Research Group. Chronic care model and shared careindiabetes:randomizedtrialofanelectronic decision support system. Mayo Clin Proc 2008; 83:747–757 38. Stone RA, Rao RH, Sevick MA, et al. Active care management supported by home tele- monitoring in veterans with type 2 diabetes: the DiaTel randomized controlled trial. Diabetes Care 2010;33:478–484 39. Bojadzievski T, Gabbay RA. Patient-centered medical home and diabetes. Diabetes Care 2011; 34:1047–1053 40. American Telemedicine Association. About telemedicine [Internet]. Available from http:// www.americantelemed.org/main/about/about- telemedicine/telemedicine-faqs. Accessed 2 October 2018 41. Lee SWH, Chan CKY, Chua SS, Chaiyakunapruk N. Comparative effectiveness of telemedicine strategies on type 2 diabetes management: a systematic review and network meta-analysis. Sci Rep 2017;7:12680 42. Faruque LI, Wiebe N, Ehteshami-Afshar A, et al.; Alberta Kidney Disease Network. Effect of telemedicine on glycated hemoglobin in diabe- tes: a systematic review and meta-analysis of randomized trials. CMAJ 2017;189:E341–E364 43. Marcolino MS, Maia JX, Alkmim MBM, Boersma E, Ribeiro AL. Telemedicine application in the care of diabetes patients: systematic review and meta-analysis. PLoS One 2013;8:e79246 44. Heitkemper EM, Mamykina L, Travers J, Smaldone A. Do health information technology self-management interventions improve glyce- mic control in medically underserved adults with diabetes? A systematic review and meta-analysis. J Am Med Inform Assoc 2017;24:1024–1035 45. Myerson R, Laiteerapong N. The Affordable Care Act and diabetes diagnosis and care: ex- ploring the potential impacts. Curr Diab Rep 2016;16:27 46. Casagrande SS, McEwen LN, Herman WH. Changes in health insurance coverage under the Affordable Care Act: a national sample of U.S. adults with diabetes, 2009 and 2016. Diabetes Care 2018;41:956–962 47. Doucette ED, Salas J, Scherrer JF. Insurance coverage and diabetes quality indicators among patients in NHANES. Am J Manag Care 2016;22: 484–490 48. Stiefel M, Nolan K. Measuring the triple aim: a call for action. Popul Health Manag 2013;16: 219–220 49. Agency for Healthcare Researchand Quality. About the National Quality Strategy [Internet], 2017. Available from https://www.ahrq.gov/ workingforquality/about/index.html. Accessed 22 October 2018 50. National Quality Forum. Home page [Internet], 2017. Available from http://www.qualityforum .org/home.aspx. Accessed 22 October 2018 51. Burstin H, Johnson K. Getting to better care and outcomes for diabetes through measure- ment [article online], 2016. Available from http://www.ajmc.com/journals/evidence-based- diabetes-management/2016/march-2016/getting- to-better-care-and-outcomes-for-diabetes-through- measurement. Accessed 22 October 2018 52. National Institute of Diabetes and Diges- tive and Kidney Diseases. Practice transformation for physicians & health care teams [Internet]. Available from https://www.niddk.nih.gov/ health-information/health-communication- programs/ndep/health-care-professionals/ practice-transformation/Pages/resourcedetail .aspx. Accessed 22 October 2018 care.diabetesjournals.org Improving Care and Promoting Health S11
  • 20. 53. National Institute of Diabetes and Digestive and Kidney Diseases. Diabetes care and quality: past,present,andfuture[Internet].Availablefrom https://www.niddk.nih.gov/health-information/ health-communication-programs/ndep/health- care-professionals/practice-transformation/ defining-quality-care/diabetes-care-quality/Pages/ default.aspx. Accessed 22 October 2018 54. O’Connor PJ, Sperl-Hillen JM, Fazio CJ, Averbeck BM, Rank BH, Margolis KL. Outpatient diabetes clinical decision support: current status and future directions. Diabet Med 2016;33:734–741 55. Centers for Medicare & Medicaid Services. CMS Equity Plan for Medicare [Internet]. Avail- able from https://www.cms.gov/About-CMS/ Agency-Information/OMH/equity-initiatives/ equity-plan.html. Accessed 22 October 2018 56. Rosenthal MB, Cutler DM, Feder J. The ACO rules–striking the balance betweenparticipation and transformative potential. N Engl J Med 2011;365:e6 57. Washington AE, Lipstein SH. The Patient- Centered Outcomes Research Institute–promoting better information, decisions, and health. N Engl J Med 2011;365:e31 58. Hutchinson RN, Shin S. Systematic review of health disparities for cardiovascular diseasesand associated factors among American Indian and Alaska Native populations. PLoS One 2014;9: e80973 59. Borschuk AP, Everhart RS. Health disparities among youth with type 1 diabetes: a systematic review of the current literature. Fam Syst Health 2015;33:297–313 60. Walker RJ, Strom Williams J, Egede LE. In- fluenceofrace,ethnicityandsocialdeterminants of health on diabetes outcomes. Am J Med Sci 2016;351:366–373 61. Patel MR, Piette JD, Resnicow K, Kowalski- Dobson T, Heisler M. Social determinants of health, cost-related nonadherence, and cost- reducing behaviors among adults with diabetes: findings from the National Health Interview Survey. Med Care 2016;54:796–803 62. Steve SL, Tung EL, Schlichtman JJ, Peek ME. Social disorder in adults with type 2 diabetes: building on race, place, and poverty. Curr Diab Rep 2016;16:72 63. World Health Organization Commission on Social Determinants of Health. Closing the gap in a generation: health equity through action on the social determinants of health [Internet], 2008. Geneva, Switzerland, World Health Organiza- tion. Available from http://www.who.int/social_ determinants/final_report/csdh_finalreport_2008 .pdf. Accessed 22 October 2018 64. Hill JO, Galloway JM, Goley A, et al. Socio- ecological determinants of prediabetes and type 2 diabetes. Diabetes Care 2013;36:2430– 2439 65. National Academies of Sciences, Engineer- ing, and Medicine. A Framework to Address the Social Determinants of Health [Internet], 2016. Washington, DC, The National Academies Press. Available from https://www.nap.edu/ catalog/21923/a-framework-for-educating-health- professionals-to-address-the-social-determinants- of-health. Accessed 22 October 2018 66. Institute of Medicine. Capturing social and behavioral domains and measures in electronic health records: phase 2 [Internet], 2014. Wash- ington, DC, The National Academies Press. Avail- ablefromhttps://www.nap.edu/catalog/18951/ capturing-social-and-behavioral-domains-and- measures-in-electronic-health-records. Accessed 22 October 2018 67. Chin MH, Clarke AR, Nocon RS, et al. A roadmap and best practices for organizations to reduce racial and ethnic disparities in health care. J Gen Intern Med 2012;27:992–1000 68. National Quality Forum. National voluntary consensus standards for ambulatory cared measuring healthcare disparities [Internet], 2008. Available from https://www.qualityforum.org/ Publications/2008/03/National_Voluntary_ Consensus_Standards_for_Ambulatory_Care% E2%80%94Measuring_Healthcare_Disparities .aspx. Accessed 22 October 2018 69. Piette JD, Heisler M, Wagner TH. Cost- related medication underuse among chronically ill adults: the treatments people forgo, how often, and who is at risk. Am J Public Health 2004;94:1782–1787 70. Laiteerapong N, Karter AJ, Liu JY, et al. Correlates of quality of life in older adults with diabetes: the Diabetes & Aging Study. Di- abetes Care 2011;34:1749–1753 71. Heerman WJ, Wallston KA, Osborn CY, et al. Food insecurity is associated with diabetes self- care behaviours and glycaemic control. Diabet Med 2016;33:844–850 72. Silverman J, Krieger J, Kiefer M, Hebert P, Robinson J, Nelson K. The relationship between food insecurity and depression, diabetes distress and medication adherence among low-income patients with poorly-controlled diabetes. J Gen Intern Med 2015;30:1476–1480 73. Hager ER, Quigg AM, Black MM, et al. De- velopment and validity of a 2-item screen to identify families at risk for food insecurity. Pe- diatrics 2010;126:e26–e32 74. Seligman HK, Schillinger D. Hunger and socioeconomic disparities in chronic disease. N Engl J Med 2010;363:6–9 75. Montgomery AE, Fargo JD, Kane V, Culhane DP. Development and validation of an instrument to assess imminent risk of homelessness among veterans. Public Health Rep 2014;129:428–436 76. U.S. Department of Health and Human Ser- vices. Think cultural health [Internet]. Available from https://www.thinkculturalhealth.hhs.gov/. Accessed 22 October 2018 77. Agency for Healthcare Researchand Quality. Clinical-community linkages [Internet]. Avail- able from http://www.ahrq.gov/professionals/ prevention-chronic-care/improve/community/ index.html. Accessed 22 October 2018 78. Shah M, Kaselitz E, Heisler M. The role of community health workers in diabetes: update on currentliterature.CurrDiabRep2013;13:163–171 79. Heisler M, Vijan S, Makki F, Piette JD. Di- abetes control with reciprocal peer support versus nurse care management: a randomized trial. Ann Intern Med 2010;153:507–515 80. Long JA, Jahnle EC, Richardson DM, Loewenstein G, Volpp KG. Peer mentoring and financial incentives to improve glucose control in African American veterans: a random- ized trial. Ann Intern Med 2012;156:416–424 81. Fisher EB, Boothroyd RI, Elstad EA, et al. Peer support of complex health behaviors in preven- tion and disease management with special ref- erence to diabetes: systematic reviews. Clin Diabetes Endocrinol 2017;3:4 82. Foster G, Taylor SJC, Eldridge SE, Ramsay J, Griffiths CJ. Self-management education pro- grammes by lay leaders for people with chronic conditions. Cochrane Database Syst Rev 2007;4: CD005108 83. Rosenthal EL, Rush CH, Allen CG; Project on CHW Policy & Practice. Understanding scope and competencies: a contemporary look at the United States community health worker field: progress report of the Community Health Worker (CHW) Core Consensus (C3) Project: building national consensus on CHW core roles, skills, and qualities [Internet], 2016. Available from http://files.ctctcdn.com/a907c850501/1c1289f0- 88cc-49c3-a238-66def942c147.pdf. Accessed 22 October 2018 84. U.S. Department of Health and Human Ser- vices. Community health workers help patients manage diabetes [Internet]. Available from https://www.thecommunityguide.org/content/ community-health-workers-help-patients-manage- diabetes. Accessed 22 October 2018 S12 Improving Care and Promoting Health Diabetes Care Volume 42, Supplement 1, January 2019
  • 21. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetesd2019 Diabetes Care 2019;42(Suppl. 1):S13–S28 | https://doi.org/10.2337/dc19-S002 The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes” includes ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations, please refer to the Standards of Care Introduction. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC. CLASSIFICATION Diabetes can be classified into the following general categories: 1. Type1diabetes(duetoautoimmuneb-celldestruction,usuallyleadingtoabsolute insulin deficiency) 2. Type 2 diabetes (due to a progressive loss of b-cell insulin secretion frequently on the background of insulin resistance) 3. Gestational diabetes mellitus (GDM) (diabetes diagnosed in the second or third trimester of pregnancy that was not clearly overt diabetes prior to gestation) 4. Specific types of diabetes due to other causes, e.g., monogenic diabetes syndromes (such as neonatal diabetes and maturity-onset diabetes of the young [MODY]), diseases of the exocrine pancreas (such as cystic fibrosis and pancreatitis), and drug- or chemical-induced diabetes (such as with glucocorticoid use, in the treatment of HIV/AIDS, or after organ transplantation) This section reviews most common forms of diabetes but is not comprehensive. For additional information, see the American Diabetes Association (ADA) position statement “Diagnosis and Classification of Diabetes Mellitus” (1). Type 1 diabetes and type 2 diabetes are heterogeneous diseases in which clinical presentation and disease progression may vary considerably. Classification is im- portant for determining therapy, but some individuals cannot be clearly classified as having type 1 or type 2 diabetes at the time of diagnosis. The traditional paradigms of type 2 diabetes occurring only in adults and type 1 diabetes only in children are no longer accurate, as both diseases occur in both age-groups. Children with type 1 diabetes typically present with the hallmark symptoms of polyuria/polydipsia, and approximately one-third present with diabetic ketoacidosis (DKA) (2). The onset of type 1 diabetes may be more variable in adults, and they may not present with the Suggested citation: American Diabetes Associa- tion. 2. Classification and diagnosis of diabetes: Standards of Medical Care in Diabetesd2019. Diabetes Care 2019;42(Suppl. 1):S13–S28 © 2018 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More infor- mation is available at http://www.diabetesjournals .org/content/license. American Diabetes Association Diabetes Care Volume 42, Supplement 1, January 2019 S13 2.CLASSIFICATIONANDDIAGNOSISOFDIABETES
  • 22. classic symptoms seen in children. Oc- casionally, patients with type 2 diabetes may present with DKA, particularly ethnic minorities (3). Although difficulties in distinguishing diabetes type may occur in all age-groups at onset, the true diag- nosis becomes more obvious over time. In both type 1 and type 2 diabetes, various genetic and environmental fac- tors can result in the progressive loss of b-cell mass and/or function that mani- fests clinically as hyperglycemia. Once hyperglycemia occurs, patients with all forms of diabetes are at risk for devel- oping the same chronic complications, although rates of progression may differ. The identification of individualized ther- apies for diabetes in the future will re- quirebettercharacterization ofthemany paths to b-cell demise or dysfunction (4). Characterization of the underlying pathophysiology is more developed in type 1 diabetes than in type 2 diabetes. It is now clear from studies of first-degree relatives of patients with type 1 diabetes that the persistent presence of two or more autoantibodies is an almost certain predictor of clinical hyperglycemia and diabetes. The rate of progression is de- pendent on the age at first detection of antibody, number of antibodies, anti- body specificity, and antibody titer. Glu- cose and A1C levels rise well before the clinical onset of diabetes, making diag- nosis feasible well before the onset of DKA. Three distinct stages of type 1 di- abetes can be identified (Table 2.1) and serve as a framework for future research and regulatory decision making (4,5). The paths to b-cell demise and dys- function are less well defined in type 2 diabetes, but deficient b-cell insulin secretion, frequently in the setting of insulin resistance, appears to be the common denominator. Characterization of subtypes of this heterogeneous dis- order have been developed and vali- dated in Scandinavian and Northern European populations but have not been confirmed in other ethnic and racial groups. Type 2 diabetes is primarily as- sociated with insulin secretory defects related to inflammation and metabolic stress among other contributors, includ- ing genetic factors. Future classification schemes for diabetes will likely focus on the pathophysiology of the underly- ing b-cell dysfunction and the stage of disease as indicated by glucose status (normal, impaired, or diabetes) (4). DIAGNOSTIC TESTS FOR DIABETES Diabetes may be diagnosed based on plasma glucose criteria, either the fasting plasma glucose (FPG) value or the 2-h plasma glucose (2-h PG) value during a 75-g oral glucose tolerance test (OGTT), or A1C criteria (6) (Table 2.2). Generally, FPG, 2-h PG during 75-g OGTT, and A1C are equally appropriate for diagnostic testing. It should be noted that the tests do not necessarily detect diabetes in the same individuals. The efficacy of interventions for primary pre- vention of type 2 diabetes (7,8) has primarily been demonstrated among in- dividuals who have impaired glucose tolerance (IGT) with or without elevated fasting glucose, not for individuals with isolated impaired fasting glucose (IFG) or for those with prediabetes defined by A1C criteria. The same tests may be used to screen for and diagnose diabetes and to detect individuals with prediabetes. Diabetes may be identified anywhere along the spectrum of clinical scenarios: in seem- ingly low-risk individuals who happen to haveglucosetesting,inindividualstested based on diabetes risk assessment, and in symptomatic patients. Fasting and 2-Hour Plasma Glucose The FPG and 2-h PG may be used to diagnose diabetes (Table 2.2). The con- cordance between the FPG and 2-h PG tests is imperfect, as is the concordance between A1C and either glucose-based test. Compared with FPG and A1C cut points, the 2-h PG value diagnoses more people with prediabetes and diabetes (9). A1C Recommendations 2.1 To avoid misdiagnosis or missed diagnosis, the A1C test should be performed using a method that is certified by the NGSP and stan- dardized to the Diabetes Control and Complications Trial (DCCT) assay. B 2.2 Marked discordance between mea- sured A1C and plasma glucose levels should raise the possibility of A1C assay interference due to hemoglobin variants (i.e., hemo- globinopathies) and consider- ation of using an assay without interference or plasma blood glu- cose criteria to diagnose diabe- tes. B 2.3 In conditions associated with an altered relationship between A1C and glycemia, such as sickle cell disease, pregnancy (second and third trimesters and the postpar- tum period), glucose-6-phosphate dehydrogenase deficiency, HIV, hemodialysis, recent blood loss or transfusion, or erythropoietin ther- apy, only plasma blood glucose cri- teria should be used to diagnose diabetes. B The A1C test should be performed using a method that is certified by the NGSP (www.ngsp.org) and standardized or traceable to the Diabetes Control and Table 2.1—Staging of type 1 diabetes (4,5) Stage 1 Stage 2 Stage 3 Characteristics c Autoimmunity c Autoimmunity c New-onset hyperglycemia c Normoglycemia c Dysglycemia c Symptomatic c Presymptomatic c Presymptomatic Diagnostic criteria c Multiple autoantibodies c Multiple autoantibodies c Clinical symptoms c No IGT or IFG c Dysglycemia: IFG and/or IGT c Diabetes by standard criteria c FPG 100–125 mg/dL (5.6–6.9 mmol/L) c 2-h PG 140–199 mg/dL (7.8–11.0 mmol/L) c A1C 5.7–6.4% (39–47 mmol/mol) or $10% increase in A1C S14 Classification and Diagnosis of Diabetes Diabetes Care Volume 42, Supplement 1, January 2019
  • 23. Complications Trial (DCCT) reference assay. Although point-of-care A1C assays may be NGSP certified or U.S. Food and Drug Administration approved for diag- nosis, proficiency testing is not always mandated for performing the test. There- fore, point-of-care assays approved for diagnostic purposes should only be con- sidered in settings licensed to perform moderate-to-high complexity tests. As discussed in Section 6 “Glycemic Targets,” point-of-care A1C assays may be more generally applied for glucose monitoring. The A1C has several advantages com- pared with the FPG and OGTT, including greater convenience (fasting not re- quired), greater preanalytical stability, and less day-to-day perturbations during stress and illness. However, these ad- vantages may be offset by the lower sensitivity of A1C at the designated cut point,greatercost, limitedavailabilityof A1C testing in certain regions of the de- veloping world, and the imperfect corre- lation between A1C and average glucose in certain individuals. The A1C test, with a diagnostic threshold of $6.5% (48 mmol/mol), diagnoses only 30% of the diabetes cases identified collectively using A1C, FPG, or 2-h PG, according to National Health and Nutrition Exam- ination Survey (NHANES) data (10). When using A1C to diagnose diabetes, it is important to recognize that A1C is an indirect measure of average blood glu- cose levels and to take other factors into consideration that may impact hemoglo- bin glycation independently of glycemia including HIV treatment (11,12), age, race/ ethnicity, pregnancy status, genetic back- ground, and anemia/hemoglobinopathies. Age The epidemiological studies that formed the basis for recommending A1C to di- agnose diabetes included only adult pop- ulations (10). However, a recent ADA clinical guidance concluded that A1C, FPG, or 2-h PG can be used to test for prediabetes or type 2 diabetes in chil- dren and adolescents. (see p. S20 SCREEN- ING AND TESTING FOR PREDIABETES AND TYPE 2 DIABETES IN CHILDREN AND ADOLESCENTS for ad- ditional information) (13). Race/Ethnicity/Hemoglobinopathies Hemoglobin variants can interfere with the measurement of A1C, although most assays inuse in theU.S. are unaffected by the most common variants. Marked dis- crepancies between measured A1C and plasma glucose levels should prompt consideration that the A1C assay may not be reliable for that individual. For patients with a hemoglobin variant but normal red blood cell turnover, such as those with the sickle cell trait, an A1C assay without interference from hemo- globin variants should be used. An up- dated list of A1C assays with interferences is available at www.ngsp.org/interf.asp. African Americans heterozygous for the common hemoglobin variant HbS may have, for any given level of mean glycemia, lower A1C by about 0.3% than those without the trait (14). Another ge- neticvariant,X-linkedglucose-6-phosphate dehydrogenase G202A, carried by 11% of African Americans, was associated with a decrease in A1C of about 0.8% in homozygous men and 0.7% in homo- zygous women compared with those without the variant (15). Even in the absence of hemoglobin variants, A1C levels may vary with race/ ethnicity independently of glycemia (16–18). For example, African Americans may have higher A1C levels than non- Hispanic whites with similar fasting and postglucose load glucose levels (19), and A1C levels may be higher for a given mean glucose concentration when measured with continuous glucose monitoring (20). Though conflicting data exists, African Americans may also have higher levels of fructosamine and glycated albumin and lower levels of 1,5-anhydroglucitol, suggest- ing that their glycemic burden (particularly postprandially) may be higher (21,22). The association of A1C with risk for complica- tions appears to be similar in African Amer- icans and non-Hispanic whites (23,24). Other Conditions Altering the Relationship of A1C and Glycemia In conditions associated with increased red blood cell turnover, such as sickle cell disease, pregnancy (second and third trimesters), glucose-6-phosphate dehy- drogenase deficiency (25,26), hemodialy- sis, recent blood loss or transfusion, or erythropoietin therapy, only plasma blood glucosecriteriashouldbeused todiagnose diabetes (27). A1C is less reliable than blood glucose measurement in other con- ditions such as postpartum (28–30), HIV treated with certain drugs (11), and iron- deficient anemia (31). Confirming the Diagnosis Unless there is a clear clinical diagnosis (e.g., patient in a hyperglycemic crisis or with classic symptoms of hyperglyce- mia and a random plasma glucose $200 mg/dL[11.1mmol/L]),diagnosisrequires two abnormal test results from the same sample (32) or in two separate test samples. If using two separate test samples, it is recommended that the second test, which may either be a repeat of the initial test or a different test, be performed without delay. For example, if the A1C is 7.0% (53 mmol/mol) and a repeat result is 6.8% (51 mmol/mol), the diagnosis of diabetes is confirmed. If two different tests (such as A1C and FPG) are both above the diagnostic threshold when analyzed from the same sample or in two different test samples, this also confirms the diagnosis. On the other hand, if a patient has discordant results Table 2.2—Criteria for the diagnosis of diabetes FPG $126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h.* OR 2-h PG $200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water.* OR A1C $6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay.* OR In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose $200 mg/dL (11.1 mmol/L). *In the absence of unequivocal hyperglycemia, diagnosis requires two abnormal test results from the same sample or in two separate test samples. care.diabetesjournals.org Classification and Diagnosis of Diabetes S15
  • 24. from two different tests, then the test result that is above the diagnostic cut point should be repeated, with consider- ation of the possibility of A1C assay in- terference. The diagnosis is made on the basis of the confirmed test. For example, if a patient meets the diabetes criterion of the A1C (two results $6.5% [48 mmol/mol]) but not FPG (,126 mg/dL [7.0 mmol/L]), that person should never- theless be considered to have diabetes. Since all the tests have preanalytic and analytic variability, it is possible that an abnormal result (i.e., above the diagnostic threshold), when repeated, will produce a value below the diagnostic cut point. This scenario is likely for FPG and2-hPGif the glucose samples remain at room tem- peratureandarenotcentrifugedpromptly. Because of the potential for preanalytic variability, it is critical that samples for plasma glucose be spun and separated immediately after they are drawn. If pa- tientshavetestresultsnearthemarginsof the diagnostic threshold, the health care professional should follow the patient closely and repeat the test in 3–6 months. TYPE 1 DIABETES Recommendations 2.4 Plasma blood glucose rather than A1C should be used to diagnose the acute onset of type 1 diabetes in individuals with symptoms of hyperglycemia. E 2.5 Screening for type 1 diabetes risk with a panel of autoantibodies is currently recommended only in the setting of a research trial or in first-degree family members of a proband with type 1 diabetes. B 2.6 Persistence of two or more auto- antibodies predicts clinical diabe- tes and may serve as an indication for intervention in the setting of a clinical trial. B Diagnosis In a patient with classic symptoms, mea- surement of plasma glucose is sufficient to diagnose diabetes (symptoms of hy- perglycemia or hyperglycemic crisis plus a random plasma glucose $200 mg/dL [11.1 mmol/L]). In these cases, knowing the plasma glucose level is critical be- cause, in addition to confirming that symptoms are due to diabetes, it will in- form management decisions. Some pro- viders may also want to know the A1C to determine how long a patient has had hyperglycemia. The criteria to diagnose diabetes are listed in Table 2.2. Immune-Mediated Diabetes This form, previously called “insulin- dependent diabetes” or “juvenile-onset diabetes,”accountsfor5–10%ofdiabetes and is due to cellular-mediated auto- immune destruction of the pancreatic b-cells. Autoimmune markers include islet cell autoantibodies and autoantibodies to GAD (GAD65), insulin, the tyrosine phos- phatases IA-2 and IA-2b, and ZnT8. Type 1 diabetes is defined by the presence of one or more of these autoimmune markers. The disease has strong HLA associations, with linkage to the DQA and DQB genes. These HLA-DR/DQ alleles can be either predisposing or protective. The rate of b-cell destruction is quite variable, being rapid in some individuals (mainly infants and children) and slow in others (mainly adults). Children and ado- lescents may present with DKA as the first manifestation of the disease. Others have modest fasting hyperglycemia that can rapidly change to severe hyper- glycemia and/or DKA with infection or other stress. Adults may retain sufficient b-cell function to prevent DKA for many years; such individuals eventually be- come dependent on insulin for survival and are at risk for DKA. Atthis latter stage of the disease, there is little or no insulin secretion, as manifested by low or un- detectable levels of plasma C-peptide. Immune-mediated diabetes commonly occurs in childhood and adolescence, but it can occur at any age, even in the 8th and 9th decades of life. Autoimmune destruction of b-cells has multiple genetic predispositions and is also related to environmental factors that are still poorly defined. Al- though patients are not typically obese when they present with type 1 diabetes, obesity should not preclude the diagno- sis. People with type 1 diabetes are also prone to other autoimmune disorders such as Hashimoto thyroiditis, Graves dis- ease, Addison disease, celiac disease, vit- iligo, autoimmune hepatitis, myasthenia gravis, and pernicious anemia (see Section 4 “Comprehensive Medical Evaluation and Assessment of Comorbidities”). Idiopathic Type 1 Diabetes Some forms of type 1 diabetes have no known etiologies. These patients have permanent insulinopenia and are prone to DKA, but have no evidence of b-cell autoimmunity. Although only a minority of patients with type 1 diabetes fall into this category, of those who do, most are of African or Asian ancestry. Individuals with this form of diabetes suffer from episodic DKA and exhibit varying degrees of insulin deficiency between episodes. This form of diabetes is strongly inherited and is not HLA associated. An absolute require- ment for insulin replacement therapy in affected patients may be intermittent. Screening for Type 1 Diabetes Risk The incidence and prevalence of type 1 diabetes is increasing (33). Patients with type 1 diabetes often present with acute symptoms of diabetes and markedly elevated blood glucose levels, and ap- proximately one-third are diagnosed with life-threatening DKA (2). Several studies indicate that measuring islet autoantibodies in relatives of those with type 1 diabetes may identify indi- viduals who are at risk for developing type 1 diabetes (5). Such testing, coupled with education about diabetes symp- toms and close follow-up, may enable earlier identification of type 1 diabetes onset. A study reported the risk of pro- gression to type 1 diabetes from the time of seroconversion to autoantibody pos- itivity in three pediatric cohorts from Finland, Germany, and the U.S. Of the 585 children who developed more than two autoantibodies, nearly 70% devel- oped type 1 diabetes within 10 years and 84% within 15 years (34). These findings are highly significant because while the German group was recruited from off- spring of parents with type 1 diabetes, the Finnish and American groups were recruited from the general population. Remarkably, the findings in all three groups were the same, suggesting that the same sequence of events led to clinical disease in both “sporadic” and familial cases of type 1 diabetes. Indeed, the risk of type 1 diabetes increases as the number of relevant autoantibodies detected increases (35–37). Although there is currently a lack of accepted screening programs, one should consider referring relatives of those with type 1 diabetes for antibody testing for risk assessment in the setting of a clini- cal research study (www.diabetestrialnet .org). Widespread clinical testing of asymp- tomatic low-risk individuals is not currently S16 Classification and Diagnosis of Diabetes Diabetes Care Volume 42, Supplement 1, January 2019